Page last updated: 2024-12-06

escitalopram

Description Research Excerpts Clinical Trials Roles Classes Pathways Study Profile Bioassays Related Drugs Related Conditions Protein Interactions Research Growth

Description

Escitalopram: S-enantiomer of CITALOPRAM. Belongs to a class of drugs known as SELECTIVE SEROTONIN REUPTAKE INHIBITORS, used to treat depression and generalized anxiety disorder. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

escitalopram : A 1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrile that has S-configuration at the chiral centre. It is the active enantiomer of citalopram. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID146570
CHEMBL ID1508
CHEBI ID36791
SCHEMBL ID34948
MeSH IDM0406596

Synonyms (93)

Synonym
BIDD:PXR0135
AC-1594
AB00698374-09
BRD-K70301876-034-02-0
seroplex
cipralex
s-(+)-citalopram
CHEBI:36791 ,
(s)-citalopram
escitalopram
escitalopramum
s(+)-citalopram
(+)-citalopram
esertia
128196-01-0
(1s)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrile
SPECTRUM_001401
BSPBIO_002644
NCGC00015267-01
tocris-1427
NCGC00025160-01
lopac-c-7861
NCGC00178555-01
SPECTRUM5_001693
DB01175
5-isobenzofurancarbonitrile, 1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydro-, (1s)-
(+)-(s)-1-(3-(dimethylamino)propyl)-1-(p-fluorophenyl)-5-phthalancarbonitrile
escitalopram [inn]
KBIOSS_001881
KBIO2_004449
KBIO2_007017
KBIOGR_001644
KBIO3_001864
KBIO2_001881
SPECTRUM3_001062
SPBIO_000621
SPECTRUM2_000551
SPECTRUM4_001212
NCGC00015267-02
HMS2089O08
CHEMBL1508 ,
lu-26-054
esitol
escitalopram (inn)
esertia (tn)
D07913
bdbm50302225
(1s)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-3h-2-benzofuran-5-carbonitrile
(1r)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-3h-isobenzofuran-5-carbonitrile
A805793
hsdb 8410
unii-4o4s742any
escitalopram [inn:ban]
4o4s742any ,
NCGC00015267-06
NCGC00015267-03
gtpl7177
AKOS017343470
escitalopram [vandf]
s-(+)-5-isobenzofurancarbonitrile, 1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydro-
escitalopram [ep monograph]
s-(+)-1-(3-(dimethylamino)propyl)-1-(p-fluorophenyl)-5-phthalancarbonitrile
escitalopram [mi]
escitalopram [who-dd]
HY-14258
CS-2053
AB00698374-07
SCHEMBL34948
(s)-(+)-1-[3-(dimethylamino) propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofuran carbonitrile
(s)-(+)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-5-isobenzofuran carbonitrile
WSEQXVZVJXJVFP-FQEVSTJZSA-N
DTXSID8048440 ,
(s)-1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile ,
AB00698374_10
68P ,
J-005570
AC-4508
(s)-1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5 carbonitrile
MRF-0000226
(s)-citalopram;s-(+)-citalopram
Q423757
BCP12154
SB17453
5-isobenzofurancarbonitrile, 1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-, (1s)-
2-methoxyethylp-toluenesulfonate
NCGC00178555-07
EN300-18530974
ps28 - escitalopram
n06ab10
dtxcid4028414
isobenzofurancarbonitrile, 1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydro-, (1s)-
escitalopram (ep monograph)
(1s)-1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrile

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Pharmacological treatment may cause adverse drug reactions and sexual side effects."( Toxic effect of antidepressants on male reproductive system cells: evaluation of possible fertility reduction mechanism.
Koziorowski, M; Mytych, J; Solek, P; Sowa-Kucma, M; Tabecka-Lonczynska, A, 2021
)
0.62
"To report side effect frequency and severity in patients with major depressive disorder (MDD) receiving escitalopram and aripiprazole adjunctive therapy and to examine whether pretreatment anxious depression is associated with the number and presence of specific side effects."( Pretreatment anxious depression as a predictor of side effect frequency and severity in escitalopram and aripiprazole adjunctive therapy.
Bhat, V; Demchenko, I; Espinola, CW; Frey, BN; Ho, K; Kennedy, SH; Khoo, Y; Lam, RW; Lou, W; Milev, RV; Parikh, SV; Parmar, R; Ravindran, AV; Rotzinger, S, 2022
)
0.72
" This might lead to polypharmacy and increase adverse events representing major threats to the quality of health care, especially in palliative care situations."( What is the effectiveness and safety of mirtazapine versus escitalopram in alleviating cancer-associated poly-symptomatology (the MIR-P study)? A mixed-method randomized controlled trial protocol.
Alexandre, M; Economos, G; Glehen, O; Haesebaert, J; Perceau-Chambard, E; Subtil, F; Villeneuve, L, 2022
)
0.72
" This could lead to important changes in the management of those patients by using a single molecule to alleviate multiple symptoms at a same time, potentially improving medication adherence, symptoms' control, and reducing the risk of medications adverse events."( What is the effectiveness and safety of mirtazapine versus escitalopram in alleviating cancer-associated poly-symptomatology (the MIR-P study)? A mixed-method randomized controlled trial protocol.
Alexandre, M; Economos, G; Glehen, O; Haesebaert, J; Perceau-Chambard, E; Subtil, F; Villeneuve, L, 2022
)
0.72
"The concomitant use of MPHs and SSRIs showed generally safe profiles in adolescent ADHD patients with depression."( Safety outcomes of selective serotonin reuptake inhibitors in adolescent attention-deficit/hyperactivity disorder with comorbid depression:
Alhambra, DP; Kim, C; Kim, SJ; Lee, DY; Lee, J; Lee, S; Lee, YH; Park, J; Park, RW; Shin, Y; Tan, EH; Yang, SJ, 2023
)
0.91

Pharmacokinetics

ExcerptReferenceRelevance
" Genetic polymorphisms that manifest as highly variable pharmacodynamic and pharmacokinetic measures are its expected causes."( Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
Cremers, TI; Flik, G; Hofland, C; Stratford, RE, 2012
)
0.38
"Fifty-five pregnant women with Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) diagnoses of affective disorders, treated with SSRIs/SNRIs, were recruited and, during the third trimester, their blood samples were collected for pharmacokinetic and pharmacogenetic analyses."( Correlation between pharmacokinetics and pharmacogenetics of Selective Serotonin Reuptake Inhibitors and Selective Serotonin and Noradrenaline Reuptake Inhibitors and maternal and neonatal outcomes: Results from a naturalistic study in patients with affec
Bosi, MF; Cafaro, R; Cetin, I; Clementi, E; Colombo, A; Dell'Osso, B; Di Bernardo, I; Giordano, F; Giorgetti, F; Pileri, P; Varinelli, A; Viganò, CA, 2021
)
0.62
" A significant difference between male and female Cmax (maximum plasma concentration) (P = 0."( Validated LC/MS/MS Method for the Determination of Rivastigmine in Human Plasma: Application to a Pharmacokinetic Study in Egyptian Volunteers to Determine the Effect of Gender and Body Mass Index.
ElKady, EF; Mostafa, EA, 2023
)
0.91
" Pharmacokinetic studies of SCIT have demonstrated considerable interindividual variability, emphasizing the need for personalized dosing."( Escitalopram Personalized Dosing: A Population Pharmacokinetics Repository Method.
Chen, L; He, Q; Ju, G; Liu, X; Ouyang, D; Xu, N; Yang, W; Zhu, X, 2023
)
0.91
" This study aims to develop a population pharmacokinetic (popPK) model characterizes the disposition of SCIT in the Chinese population."( Escitalopram population pharmacokinetics and remedial strategies based on CYP2C19 phenotype.
Chen, L; He, Q; Huang, X; Ju, G; Li, C; Liu, X; Ouyang, D; Xu, N; Yang, W; Zhu, X, 2024
)
1.44

Compound-Compound Interactions

escitalopram combined with BoNT/A should be given as early as possible in GAD patients and comorbid headache.

ExcerptReferenceRelevance
" Therefore, our study aimed to investigate the clinical efficacy of escitalopram combined with botulinum toxin A (BoNT/A) in patients with GAD and comorbid headache and seek an alternative treatment strategy for the comorbidity of GAD and headache."( Clinical efficacy of escitalopram combined with botulinum toxin A in patients with generalized anxiety disorder and comorbid headache.
Ji, X; Liu, M; Wang, Y; Yang, X; Zhou, C, 2023
)
0.91
" Therefore, we recommend that escitalopram combined with BoNT/A should be given as early as possible in GAD patients and comorbid headache."( Clinical efficacy of escitalopram combined with botulinum toxin A in patients with generalized anxiety disorder and comorbid headache.
Ji, X; Liu, M; Wang, Y; Yang, X; Zhou, C, 2023
)
0.91

Bioavailability

The present work aims to deliver a novel formulation for improving the dissolution profile and, thus, the bioavailability of escitalopram.

ExcerptReferenceRelevance
" Human oral bioavailability is an important pharmacokinetic property, which is directly related to the amount of drug available in the systemic circulation to exert pharmacological and therapeutic effects."( Hologram QSAR model for the prediction of human oral bioavailability.
Andricopulo, AD; Moda, TL; Montanari, CA, 2007
)
0.34
" Compound 15 was identified as a selective and high affinity NPY5 antagonist with good oral bioavailability in mice (42%) and rats (92%)."( Discovery of Lu AA33810: a highly selective and potent NPY5 antagonist with in vivo efficacy in a model of mood disorder.
Andersen, K; Chandrasena, G; Desai, M; Jubian, V; Lu, Y; Marzabadi, MR; Noble, SA; Packiarajan, M; Walker, MW; Wiborg, O; Wolinsky, TD; Wong, WC; Zhong, H, 2011
)
0.37
"To highlight the clinical efficacy, safety, recent development, and stable formulation of escitalopram with an increased bioavailability profile."( A Review of Clinical Studies Assessing the Therapeutic Efficacy of Escitalopram: A Step Towards Development.
Bhatia, V; Chopra, B; Dhingra, AK; Guarve, K, 2023
)
0.91
"The present work aims to deliver a novel formulation for improving the dissolution profile and, thus, the bioavailability of escitalopram."( Formulation, Development, and
Bhatia, V; Chopra, B; Dass, R; Dhingra, AK; Guarve, K, 2022
)
0.72
" Alterations caused by RYGB could modify drug bioavailability and cause potential subtherapeutic plasma concentrations, increasing the risk of depressive relapse."( The Influence of a Roux-en-Y Gastric Bypass on Plasma Concentrations of Antidepressants.
Eap, CB; Favre, L; Frantz, J; Garin, P; Vandenberghe, F; Vionnet, N, 2023
)
0.91

Dosage Studied

Participants were 1:1 randomized to 8 weeks of the weekly MBSR course or the antidepressant escitalopram, flexibly dosed from 10 to 20 mg. The proportion of patients dosed above the new limit decreased from 8 to 1% in patients ≤ 65 years. The ratio could be a valuable alternative to genotyping in personalized dosing of escitalsopram and possibly other CYP2C19 substrates.

ExcerptRelevanceReference
"A woman in her fifties presented with dizziness, general muscle stiffness, chills, nausea and a feeling of transient shock in her head during dosage reduction of escitalopram."( Acrodermatitis chronica atrophicans in prolonged borrelia infection.
Høiberg, HK; Lorentzen, ÅR; Noraas, S; Solheim, AM, 2021
)
0.62
" The proportion of patients dosed above the new limit decreased from 8 to 1% in patients ≤ 65 years and from 46 to 23% in patients > 65 years old for citalopram versus 14-5% and 47-31% for escitalopram."( Dear Doctor Letters regarding citalopram and escitalopram: guidelines vs real-world data.
Bleich, S; Bridler, R; de Bardeci, M; Greil, W; Grohmann, R; Hasler, G; Kasper, S; Köberle, U; Rüther, E; Seifert, J; Stassen, H; Toto, S; Willms, J, 2023
)
0.91
" Dose-response effects were not investigated because dosage instructions were not available."( Serious arrhythmia in initiators of citalopram, escitalopram, and other selective serotonin reuptake inhibitors: A population-based cohort study in older adults.
Aakjaer, M; Andersen, M; De Bruin, ML; Werther, SK, 2022
)
0.72
" However, the poor dissolution rate of escitalopram due to less water solubility is a consequential problem confronting the pharmaceutical industry in developing pharmaceutical dosage forms for oral delivery systems."( Formulation, Development, and
Bhatia, V; Chopra, B; Dass, R; Dhingra, AK; Guarve, K, 2022
)
0.72
" Our findings suggest that dosing based on CYP2C19 and CYP2D6 genotyping could improve safety and outcome in patients on ESC monotherapy."( Effects of CYP2C19 and CYP2D6 gene variants on escitalopram and aripiprazole treatment outcome and serum levels: results from the CAN-BIND 1 study.
Blier, P; Farzan, F; Foster, JA; Frey, BN; Hassel, S; Islam, F; Kennedy, SH; Lam, RW; Leri, F; Magarbeh, L; Marshe, VS; Milev, RV; Müller, DJ; Parikh, SV; Placenza, F; Rotzinger, S; Soares, CN; Strother, SC; Taylor, VH; Turecki, G; Uher, R, 2022
)
0.72
" The specific recommendation on daily dosage seems to have been better implemented than the broadly formulated contraindication of QTc-prolonging co-medication."( [Effect of the direct healthcare professional communication on citalopram and escitalopram drug utilization for inpatient treatment of anxiety disorders].
Belz, M; Degner, D; Greil, W; Grohmann, R; Köberle, U, 2022
)
0.72
" Morphometric, biometric, sperm parameters, oxidative stress analyses, and corticosterone dosage were carried out."( Effects of escitalopram treatment and chronic mild stress induced from peripuberty on spermatic parameters of adult rats.
de Oliva, SU; Fischer, LW; Mendes, TB; Miraglia, SM; Nunes, M; Simas, JN, 2023
)
0.91
"Participants were 1:1 randomized to 8 weeks of the weekly MBSR course or the antidepressant escitalopram, flexibly dosed from 10 to 20 mg."( Mindfulness-Based Stress Reduction vs Escitalopram for the Treatment of Adults With Anxiety Disorders: A Randomized Clinical Trial.
Baker, AW; Bui, E; Dutton, MA; Hoge, EA; Mete, M; Simon, NM, 2023
)
0.91
" The ratio could be a valuable alternative to genotyping in personalized dosing of escitalopram and possibly other CYP2C19 substrates."( Identification of Escitalopram Metabolic Ratios as Potential Biomarkers for Predicting CYP2C19 Poor Metabolizers.
Faraj, P; Hermansen, A; Hole, K; Molden, E, 2022
)
0.72
"Antidepressant-induced jitteriness/anxiety syndrome is characterized as anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, and (hypo)mania, which appear immediately after initiation or increased dosage of an antidepressant."( Jitteriness/anxiety syndrome caused by coadministration of celecoxib, a selective COX-2 inhibitor, with escitalopram and trazodone in a patient with depression and spondylolisthesis.
Kanno, M; Noto, K; Shirata, T; Suzuki, A; Yano, S, 2023
)
0.91
"Hot-melt extrusion (HME) and subsequent FDM 3D printing offer great potential opportunities in the formulation development and production of customized oral dosage forms with poorly soluble drugs."( Investigation of the degradation and in-situ amorphization of the enantiomeric drug escitalopram oxalate during Fused Deposition Modeling (FDM) 3D printing.
Breitkreutz, J; Hoffmann, L; Quodbach, J, 2023
)
0.91
" However, it is important to acknowledge certain limitations of our research, such as the use of a single depression induction model and limited dosing regimens."( Vitamins C and D Exhibit Similar Antidepressant Effects to Escitalopram Mediated by NOx and FKBPL in a Stress-Induced Mice Model.
Aljabali, AAA; Alqudah, A; Altaber, S; Gammoh, O; Ibrahim, A; Qnais, E; Tambuwala, MM, 2023
)
0.91
" To this aim, we conducted a dose-response study in male rats and assessed AMPH-induced hyperactivity and 50-kHz ultrasonic calling in the sender and social approach behavior evoked by playback of pro-social 50-kHz USV in the receiver."( Acute anxiogenic effects of escitalopram are associated with mild alterations in D-amphetamine-induced behavior and social approach evoked by playback of 50-kHz ultrasonic vocalizations in rats.
Schwarting, RKW; Willadsen, M; Wöhr, M, 2023
)
0.91
"Annual average treatment costs of amitriptyline, escitalopram, and fluoxetine in patients with depression at baseline with equivalent dosing as mono-drug therapy were 2765."( Cost-minimization analysis of escitalopram, fluoxetine, and amitriptyline in the treatment of depression.
Divakar, A; Raghav, MV; Rawat, VS; Salian, HH,
)
0.13
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (2)

RoleDescription
antidepressantAntidepressants are mood-stimulating drugs used primarily in the treatment of affective disorders and related conditions.
EC 3.4.21.26 (prolyl oligopeptidase) inhibitorAny EC 3.4.21.* (serine endopeptidase) inhibitor that interferes with the action of prolyl oligopeptidase (EC 3.4.21.26).
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (1)

ClassDescription
1-[3-(dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-2-benzofuran-5-carbonitrileA nitrile that is 1,3-dihydro-2-benzofuran-5-carbonitrile in which one of the hydrogens at position 1 is replaced by a p-fluorophenyl group, while the other is replaced by a 3-(dimethylamino)propyl group.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Pathways (1)

PathwayProteinsCompounds
Escitalopram Action Pathway3111

Protein Targets (29)

Potency Measurements

ProteinTaxonomyMeasurementAverage (µ)Min (ref.)Avg (ref.)Max (ref.)Bioassay(s)
15-lipoxygenase, partialHomo sapiens (human)Potency6.30960.012610.691788.5700AID887
NFKB1 protein, partialHomo sapiens (human)Potency1.12200.02827.055915.8489AID895; AID928
TDP1 proteinHomo sapiens (human)Potency33.49830.000811.382244.6684AID686978; AID686979
cytochrome P450 2D6Homo sapiens (human)Potency11.98770.00108.379861.1304AID1645840
cytochrome P450 2D6 isoform 1Homo sapiens (human)Potency26.20000.00207.533739.8107AID891
cytochrome P450 2C19 precursorHomo sapiens (human)Potency3.16230.00255.840031.6228AID899
cytochrome P450 2C9 precursorHomo sapiens (human)Potency3.16230.00636.904339.8107AID883
DNA polymerase kappa isoform 1Homo sapiens (human)Potency0.63100.031622.3146100.0000AID588579
cytochrome P450 3A4 isoform 1Homo sapiens (human)Potency1.00000.031610.279239.8107AID884; AID885
muscarinic acetylcholine receptor M1Rattus norvegicus (Norway rat)Potency8.15480.00106.000935.4813AID943; AID944
Gamma-aminobutyric acid receptor subunit piRattus norvegicus (Norway rat)Potency1.00001.000012.224831.6228AID885
Polyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)Potency15.84890.316212.765731.6228AID881
Gamma-aminobutyric acid receptor subunit beta-1Rattus norvegicus (Norway rat)Potency1.00001.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit deltaRattus norvegicus (Norway rat)Potency1.00001.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-2Rattus norvegicus (Norway rat)Potency1.00001.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-5Rattus norvegicus (Norway rat)Potency1.00001.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-3Rattus norvegicus (Norway rat)Potency1.00001.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-1Rattus norvegicus (Norway rat)Potency1.00001.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-2Rattus norvegicus (Norway rat)Potency1.00001.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-4Rattus norvegicus (Norway rat)Potency1.00001.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit gamma-3Rattus norvegicus (Norway rat)Potency1.00001.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit alpha-6Rattus norvegicus (Norway rat)Potency1.00001.000012.224831.6228AID885
Histamine H2 receptorCavia porcellus (domestic guinea pig)Potency10.41180.00638.235039.8107AID881; AID883
Gamma-aminobutyric acid receptor subunit alpha-1Rattus norvegicus (Norway rat)Potency1.00001.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit beta-3Rattus norvegicus (Norway rat)Potency1.00001.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit beta-2Rattus norvegicus (Norway rat)Potency1.00001.000012.224831.6228AID885
GABA theta subunitRattus norvegicus (Norway rat)Potency1.00001.000012.224831.6228AID885
Gamma-aminobutyric acid receptor subunit epsilonRattus norvegicus (Norway rat)Potency1.00001.000012.224831.6228AID885
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Sodium-dependent serotonin transporterHomo sapiens (human)IC50 (µMol)1.53740.00010.86458.7096AID1058859; AID1434648; AID1434653
Sodium-dependent serotonin transporterHomo sapiens (human)Ki1.31540.00000.70488.1930AID1156227; AID1231067; AID1231068; AID1422256; AID448409; AID479241
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Activation Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Sodium-dependent serotonin transporterHomo sapiens (human)EC50 (µMol)5.45000.00112.38838.7000AID1434655; AID1434656
Sodium-dependent serotonin transporterHomo sapiens (human)Kd0.00260.00010.03170.2000AID1156233
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (52)

Processvia Protein(s)Taxonomy
lipid metabolic processPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
phospholipid metabolic processPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
apoptotic processPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
negative regulation of cell population proliferationPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
positive regulation of macrophage derived foam cell differentiationPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
arachidonic acid metabolic processPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
negative regulation of cell migrationPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
prostate gland developmentPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
regulation of epithelial cell differentiationPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
positive regulation of chemokine productionPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
positive regulation of peroxisome proliferator activated receptor signaling pathwayPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
positive regulation of keratinocyte differentiationPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
negative regulation of cell cyclePolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
negative regulation of growthPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
hepoxilin biosynthetic processPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
endocannabinoid signaling pathwayPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
cannabinoid biosynthetic processPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
lipoxin A4 biosynthetic processPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
linoleic acid metabolic processPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
lipid oxidationPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
lipoxygenase pathwayPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
monoamine transportSodium-dependent serotonin transporterHomo sapiens (human)
response to hypoxiaSodium-dependent serotonin transporterHomo sapiens (human)
neurotransmitter transportSodium-dependent serotonin transporterHomo sapiens (human)
response to nutrientSodium-dependent serotonin transporterHomo sapiens (human)
memorySodium-dependent serotonin transporterHomo sapiens (human)
circadian rhythmSodium-dependent serotonin transporterHomo sapiens (human)
response to xenobiotic stimulusSodium-dependent serotonin transporterHomo sapiens (human)
response to toxic substanceSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of gene expressionSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of serotonin secretionSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of cerebellar granule cell precursor proliferationSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of synaptic transmission, dopaminergicSodium-dependent serotonin transporterHomo sapiens (human)
response to estradiolSodium-dependent serotonin transporterHomo sapiens (human)
social behaviorSodium-dependent serotonin transporterHomo sapiens (human)
vasoconstrictionSodium-dependent serotonin transporterHomo sapiens (human)
sperm ejaculationSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of neuron differentiationSodium-dependent serotonin transporterHomo sapiens (human)
positive regulation of cell cycleSodium-dependent serotonin transporterHomo sapiens (human)
negative regulation of organ growthSodium-dependent serotonin transporterHomo sapiens (human)
behavioral response to cocaineSodium-dependent serotonin transporterHomo sapiens (human)
enteric nervous system developmentSodium-dependent serotonin transporterHomo sapiens (human)
brain morphogenesisSodium-dependent serotonin transporterHomo sapiens (human)
serotonin uptakeSodium-dependent serotonin transporterHomo sapiens (human)
membrane depolarizationSodium-dependent serotonin transporterHomo sapiens (human)
platelet aggregationSodium-dependent serotonin transporterHomo sapiens (human)
cellular response to retinoic acidSodium-dependent serotonin transporterHomo sapiens (human)
cellular response to cGMPSodium-dependent serotonin transporterHomo sapiens (human)
regulation of thalamus sizeSodium-dependent serotonin transporterHomo sapiens (human)
conditioned place preferenceSodium-dependent serotonin transporterHomo sapiens (human)
sodium ion transmembrane transportSodium-dependent serotonin transporterHomo sapiens (human)
amino acid transportSodium-dependent serotonin transporterHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (21)

Processvia Protein(s)Taxonomy
iron ion bindingPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
calcium ion bindingPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
protein bindingPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
lipid bindingPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
linoleate 13S-lipoxygenase activityPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
arachidonate 8(S)-lipoxygenase activityPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
arachidonate 15-lipoxygenase activityPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
linoleate 9S-lipoxygenase activityPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
integrin bindingSodium-dependent serotonin transporterHomo sapiens (human)
monoatomic cation channel activitySodium-dependent serotonin transporterHomo sapiens (human)
neurotransmitter transmembrane transporter activitySodium-dependent serotonin transporterHomo sapiens (human)
serotonin:sodium:chloride symporter activitySodium-dependent serotonin transporterHomo sapiens (human)
protein bindingSodium-dependent serotonin transporterHomo sapiens (human)
monoamine transmembrane transporter activitySodium-dependent serotonin transporterHomo sapiens (human)
antiporter activitySodium-dependent serotonin transporterHomo sapiens (human)
syntaxin-1 bindingSodium-dependent serotonin transporterHomo sapiens (human)
cocaine bindingSodium-dependent serotonin transporterHomo sapiens (human)
sodium ion bindingSodium-dependent serotonin transporterHomo sapiens (human)
identical protein bindingSodium-dependent serotonin transporterHomo sapiens (human)
nitric-oxide synthase bindingSodium-dependent serotonin transporterHomo sapiens (human)
actin filament bindingSodium-dependent serotonin transporterHomo sapiens (human)
serotonin bindingSodium-dependent serotonin transporterHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (16)

Processvia Protein(s)Taxonomy
nucleusPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
cytosolPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
cytoskeletonPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
plasma membranePolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
adherens junctionPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
focal adhesionPolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
membranePolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
extracellular exosomePolyunsaturated fatty acid lipoxygenase ALOX15BHomo sapiens (human)
plasma membraneGamma-aminobutyric acid receptor subunit gamma-2Rattus norvegicus (Norway rat)
plasma membraneSodium-dependent serotonin transporterHomo sapiens (human)
focal adhesionSodium-dependent serotonin transporterHomo sapiens (human)
endosome membraneSodium-dependent serotonin transporterHomo sapiens (human)
endomembrane systemSodium-dependent serotonin transporterHomo sapiens (human)
presynaptic membraneSodium-dependent serotonin transporterHomo sapiens (human)
membrane raftSodium-dependent serotonin transporterHomo sapiens (human)
synapseSodium-dependent serotonin transporterHomo sapiens (human)
postsynaptic membraneSodium-dependent serotonin transporterHomo sapiens (human)
serotonergic synapseSodium-dependent serotonin transporterHomo sapiens (human)
synapseSodium-dependent serotonin transporterHomo sapiens (human)
plasma membraneSodium-dependent serotonin transporterHomo sapiens (human)
neuron projectionSodium-dependent serotonin transporterHomo sapiens (human)
plasma membraneGamma-aminobutyric acid receptor subunit alpha-1Rattus norvegicus (Norway rat)
plasma membraneGamma-aminobutyric acid receptor subunit beta-2Rattus norvegicus (Norway rat)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (68)

Assay IDTitleYearJournalArticle
AID1740921Toxicity in Wistar rat assessed as total distance travelled at 20 mg/kg, ip measured after 30 mins by open field test (Rvb = 1897.3 +/-98.6 cm)
AID620922Antistress activity against chronic mild stress Sprague-Dawley rat model assessed as increase sucrose consumption at 5 mg/kg, ip bid measured after 4 weeks2011Bioorganic & medicinal chemistry letters, Sep-15, Volume: 21, Issue:18
Discovery of Lu AA33810: a highly selective and potent NPY5 antagonist with in vivo efficacy in a model of mood disorder.
AID1211423Peripheral volume of distribution in Wistar rat extracellular fluid at 1.6 mg/kg, sc by HPLC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Oct, Volume: 40, Issue:10
Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
AID1211452Unbound AUC (0 to infinity) in Wistar rat plasma at 1.6 mg/kg, sc by HPLC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Oct, Volume: 40, Issue:10
Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
AID1211424Distributional clearance in Wistar rat extracellular fluid at 1.6 mg/kg, sc by HPLC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Oct, Volume: 40, Issue:10
Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
AID1231068Inhibition of human SERT S438T mutant expressed in HEK293 GripTite cells pre-incubated for 5 mins followed by [3H]5-HT addition by [3H]5-HT uptake assay2015Journal of medicinal chemistry, Jul-23, Volume: 58, Issue:14
Novel Azido-Iodo Photoaffinity Ligands for the Human Serotonin Transporter Based on the Selective Serotonin Reuptake Inhibitor (S)-Citalopram.
AID1211410Tmax in Wistar rat extracellular fluid at 1.6 mg/kg, sc by HPLC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Oct, Volume: 40, Issue:10
Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
AID1364783Antidepressant-like activity in C57BL/6J mouse assessed as decrease in immobility time at 5 to 20 mg/kg measured during 6 mins session by tail suspension test
AID1474166Liver toxicity in human assessed as induction of drug-induced liver injury by measuring severity class index2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1434648Displacement of [3H]-S-citalopram from human SERT primary site (S1) expressed in African green monkey COS7 cell membranes after 2 hrs by microbeta scintillation counting method2017Bioorganic & medicinal chemistry letters, 02-01, Volume: 27, Issue:3
X-ray structure based evaluation of analogs of citalopram: Compounds with increased affinity and selectivity compared with R-citalopram for the allosteric site (S2) on hSERT.
AID1211437Ratio of unbound AUC in extracellular fluid to unbound AUC in plasma of Wistar rat at 1.6 mg/kg, sc by HPLC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Oct, Volume: 40, Issue:10
Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
AID1434656Inhibition of [3H]-S-citalopram dissociation from human SERT allosteric modulator site (S2) expressed in African green monkey COS7 cell membranes after 80 mins by microbeta scintillation counting method2017Bioorganic & medicinal chemistry letters, 02-01, Volume: 27, Issue:3
X-ray structure based evaluation of analogs of citalopram: Compounds with increased affinity and selectivity compared with R-citalopram for the allosteric site (S2) on hSERT.
AID1823847Anti-antidepressant like activity in Wistar rat assessed as reduction in locomotor activity by measuring total immobility time by Forced swim test
AID1058857Ratio of dissociation half life for wild-type human SERT site S2 at 18 degC to dissociation half life for wild-type human SERT site S2 at 24 degC2013Journal of medicinal chemistry, Dec-12, Volume: 56, Issue:23
Design and synthesis of 1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile (citalopram) analogues as novel probes for the serotonin transporter S1 and S2 binding sites.
AID1211458Unbound Tmax in Wistar rat plasma at 1.6 mg/kg, sc by HPLC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Oct, Volume: 40, Issue:10
Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
AID712468Antidepression activity in sc dosed Harlan rat assessed as increase in extracellular 5HT level in ventral hippocampus region measured up to 180 mins by microdialysis method relative to vehicle-treated control2011Journal of medicinal chemistry, May-12, Volume: 54, Issue:9
Discovery of 1-[2-(2,4-dimethylphenylsulfanyl)phenyl]piperazine (Lu AA21004): a novel multimodal compound for the treatment of major depressive disorder.
AID1211440Ratio of steady state drug level in extracellular fluid to unbound drug level in plasma of Wistar rat at 1.6 mg/kg, sc by HPLC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Oct, Volume: 40, Issue:10
Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
AID499952Displacement of [3H]leucine from Leucine transporter2010Journal of medicinal chemistry, Aug-26, Volume: 53, Issue:16
Structure-activity relationships for a novel series of citalopram (1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile) analogues at monoamine transporters.
AID1740906Toxicity in Wistar rat assessed as rearings at 20 mg/kg, ip measured after 30 mins by open field test
AID1434653Inhibition of [3H]5-HT uptake by SERT primary site (S1) (unknown origin) expressed in African green monkey COS1 cells after 10 mins by TopCount scintillation counting method2017Bioorganic & medicinal chemistry letters, 02-01, Volume: 27, Issue:3
X-ray structure based evaluation of analogs of citalopram: Compounds with increased affinity and selectivity compared with R-citalopram for the allosteric site (S2) on hSERT.
AID1211455Unbound Cmax in Wistar rat plasma at 1.6 mg/kg, sc by HPLC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Oct, Volume: 40, Issue:10
Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
AID1474167Liver toxicity in human assessed as induction of drug-induced liver injury by measuring verified drug-induced liver injury concern status2016Drug discovery today, Apr, Volume: 21, Issue:4
DILIrank: the largest reference drug list ranked by the risk for developing drug-induced liver injury in humans.
AID1156230Inhibition of 2,5,6-[3H]-dopamine uptake at human DAT expressed in African green monkey COS7 cells at 10 uM incubated for 10 mins prior to radioligand addition measured after 5 mins by scintillation counting analysis2014ACS medicinal chemistry letters, Jun-12, Volume: 5, Issue:6
Novel and high affinity fluorescent ligands for the serotonin transporter based on (s)-citalopram.
AID1364794Antidepressant-like activity in Swiss albino mouse assessed as decrease in immobility time at 0.625 mg/kg measured during last 4 mins of 6 mins test by forced swim test
AID1907542Antidepressant activity in Swiss albino mouse assessed as decrease in immobility time administered via ip and measured after 60 mins by forced swim test relative to control2022European journal of medicinal chemistry, Jun-05, Volume: 236Overcoming undesirable hERG affinity by incorporating fluorine atoms: A case of MAO-B inhibitors derived from 1 H-pyrrolo-[3,2-c]quinolines.
AID1211414Central volume of distribution in Wistar rat extracellular fluid at 1.6 mg/kg, sc by HPLC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Oct, Volume: 40, Issue:10
Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
AID1434655Inhibition of [3H]-S-citalopram dissociation from SERT allosteric modulator site (S2) (unknown origin) expressed in African green monkey COS1 cell membranes by scintillation counting method2017Bioorganic & medicinal chemistry letters, 02-01, Volume: 27, Issue:3
X-ray structure based evaluation of analogs of citalopram: Compounds with increased affinity and selectivity compared with R-citalopram for the allosteric site (S2) on hSERT.
AID499951Selectivity ratio of Ki for DAT in rat caudate-putamen to Ki for SERT in rat brain stem2010Journal of medicinal chemistry, Aug-26, Volume: 53, Issue:16
Structure-activity relationships for a novel series of citalopram (1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile) analogues at monoamine transporters.
AID1211420Absorption rate constant in Wistar rat extracellular fluid at 1.6 mg/kg, sc by HPLC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Oct, Volume: 40, Issue:10
Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
AID1156231Inhibition of 2,5,6-[3H]-dopamine uptake at human NET expressed in African green monkey COS7 cells at 10 uM incubated for 10 mins prior to radioligand addition measured after 5 mins by scintillation counting analysis2014ACS medicinal chemistry letters, Jun-12, Volume: 5, Issue:6
Novel and high affinity fluorescent ligands for the serotonin transporter based on (s)-citalopram.
AID1364784Antidepressant-like activity in C57BL/6J mouse assessed as increase in average force of fights at 20 mg/kg measured during 6 mins session by tail suspension test
AID1058861Allosteric modulation at wild-type human SERT site S2 expressed in african green monkey COS7 cells assessed as inhibition of [3H]citalopram dissociation by measuring half life at 30 uM at 18 degC by scintillation counting analysis2013Journal of medicinal chemistry, Dec-12, Volume: 56, Issue:23
Design and synthesis of 1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile (citalopram) analogues as novel probes for the serotonin transporter S1 and S2 binding sites.
AID1211443Equilibration rate constant in Wistar rat brain extracellular fluid at 1.6 mg/kg, sc by HPLC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Oct, Volume: 40, Issue:10
Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
AID1211425Unbound volume of distribution in Wistar rat brain at 1.6 mg/kg, sc by HPLC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Oct, Volume: 40, Issue:10
Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
AID1690412Antidepressant-like activity in ip dosed Swiss albino mouse assessed as reduction in immobility time measured for last 4 mins of 6 mins test by forced swim test2020European journal of medicinal chemistry, Apr-01, Volume: 191Multifunctional 6-fluoro-3-[3-(pyrrolidin-1-yl)propyl]-1,2-benzoxazoles targeting behavioral and psychological symptoms of dementia (BPSD).
AID1211431Efflux clearance in Wistar rat brain extracellular fluid at 1.6 mg/kg, sc by HPLC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Oct, Volume: 40, Issue:10
Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
AID1211446Equilibration half life in Wistar rat brain extracellular fluid at 1.6 mg/kg, sc by HPLC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Oct, Volume: 40, Issue:10
Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
AID1231069Resistance index, ratio of Ki for human SERT S438T mutant expressed in HEK293 GripTite cells to Ki for wild type human SERT expressed in HEK293 GripTite cells2015Journal of medicinal chemistry, Jul-23, Volume: 58, Issue:14
Novel Azido-Iodo Photoaffinity Ligands for the Human Serotonin Transporter Based on the Selective Serotonin Reuptake Inhibitor (S)-Citalopram.
AID1364777Antidepressant-like activity in Swiss albino mouse assessed as decrease in immobility time at 2.5 mg/kg measured during last 4 mins of 6 mins test by forced swim test relative to control
AID1058860Allosteric modulation at wild-type human SERT site S2 expressed in african green monkey COS7 cells assessed as inhibition of [3H]citalopram dissociation by measuring half life at 30 uM at 24 degC by scintillation counting analysis2013Journal of medicinal chemistry, Dec-12, Volume: 56, Issue:23
Design and synthesis of 1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile (citalopram) analogues as novel probes for the serotonin transporter S1 and S2 binding sites.
AID448409Displacement of [3H]citalopram from human serotonin transporter expressed in HEK293 cells by scintillation proximity assay2009Bioorganic & medicinal chemistry letters, Oct-01, Volume: 19, Issue:19
Tetrahydrocarbazole-based serotonin reuptake inhibitor/dopamine D2 partial agonists for the potential treatment of schizophrenia.
AID1740909Toxicity in Wistar rat assessed as total ambulations at 20 mg/kg, ip measured after 30 mins by open field test
AID499949Displacement of [3H]WIN-35428 from DAT in rat caudate-putamen by scintillation counting2010Journal of medicinal chemistry, Aug-26, Volume: 53, Issue:16
Structure-activity relationships for a novel series of citalopram (1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile) analogues at monoamine transporters.
AID479241Displacement of [3H]citalopram form human SRET by liquid scintillation counting2010Bioorganic & medicinal chemistry letters, May-01, Volume: 20, Issue:9
Potent dihydroquinolinone dopamine D2 partial agonist/serotonin reuptake inhibitors for the treatment of schizophrenia.
AID1231067Inhibition of wild type human SERT expressed in HEK293 GripTite cells pre-incubated for 5 mins followed by [3H]5-HT addition by [3H]5-HT uptake assay2015Journal of medicinal chemistry, Jul-23, Volume: 58, Issue:14
Novel Azido-Iodo Photoaffinity Ligands for the Human Serotonin Transporter Based on the Selective Serotonin Reuptake Inhibitor (S)-Citalopram.
AID1211417Systemic clearance in Wistar rat extracellular fluid at 1.6 mg/kg, sc by HPLC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Oct, Volume: 40, Issue:10
Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
AID1434650Selectivity ratio of EC50 for inhibition of [3H]-S-citalopram dissociation from SERT allosteric modulator site (S2) (unknown origin) expressed in African green monkey COS1 cell membranes to IC50 for [3H]5-HT uptake by SERT primary site (S1) (unknown origi2017Bioorganic & medicinal chemistry letters, 02-01, Volume: 27, Issue:3
X-ray structure based evaluation of analogs of citalopram: Compounds with increased affinity and selectivity compared with R-citalopram for the allosteric site (S2) on hSERT.
AID1422256Displacement of [125I]-RTI-55 from human SERT expressed in HEK293 cell membranes after 1 hr by gamma counting method2018Bioorganic & medicinal chemistry letters, 11-15, Volume: 28, Issue:21
Clickable photoaffinity ligands for the human serotonin transporter based on the selective serotonin reuptake inhibitor (S)-citalopram.
AID1211428Uptake clearance in Wistar rat brain extracellular fluid at 1.6 mg/kg, sc by HPLC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Oct, Volume: 40, Issue:10
Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
AID311524Oral bioavailability in human2007Bioorganic & medicinal chemistry, Dec-15, Volume: 15, Issue:24
Hologram QSAR model for the prediction of human oral bioavailability.
AID1211434Ratio of uptake clearance to efflux clearance in Wistar rat brain extracellular fluid at 1.6 mg/kg, sc by HPLC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Oct, Volume: 40, Issue:10
Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
AID1211404AUC (0 to infinity) in Wistar rat extracellular fluid at 1.6 mg/kg, sc by HPLC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Oct, Volume: 40, Issue:10
Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
AID1211449Fraction unbound in Wistar rat plasma at 1.6 mg/kg, sc by HPLC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Oct, Volume: 40, Issue:10
Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
AID1211407Cmax in Wistar rat extracellular fluid at 1.6 mg/kg, sc by HPLC-MS/MS analysis2012Drug metabolism and disposition: the biological fate of chemicals, Oct, Volume: 40, Issue:10
Microdialysis evaluation of clozapine and N-desmethylclozapine pharmacokinetics in rat brain.
AID1058859Allosteric modulation at wild-type human SERT site S2 expressed in african green monkey COS7 cells assessed as inhibition of [3H]citalopram dissociation at 30 uM by scintillation counting analysis2013Journal of medicinal chemistry, Dec-12, Volume: 56, Issue:23
Design and synthesis of 1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile (citalopram) analogues as novel probes for the serotonin transporter S1 and S2 binding sites.
AID499947Displacement of [3H]citalopram from SERT in rat brain stem by scintillation counting2010Journal of medicinal chemistry, Aug-26, Volume: 53, Issue:16
Structure-activity relationships for a novel series of citalopram (1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile) analogues at monoamine transporters.
AID499948Displacement of [3H]nisoxetine from NET in rat frontal cortex by scintillation counting2010Journal of medicinal chemistry, Aug-26, Volume: 53, Issue:16
Structure-activity relationships for a novel series of citalopram (1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile) analogues at monoamine transporters.
AID1740922Antidepressant-like activity in Wistar rat assessed as reduction in immobility time at 20 mg/kg, ip measured after 30 mins by Forced swimming test
AID1156233Binding affinity to human SERT expressed in African green monkey COS7 cells after 2 hrs by scintillation counting analysis2014ACS medicinal chemistry letters, Jun-12, Volume: 5, Issue:6
Novel and high affinity fluorescent ligands for the serotonin transporter based on (s)-citalopram.
AID1364776Antidepressant-like activity in Swiss albino mouse assessed as decrease in immobility time at 1.25 mg/kg measured during last 4 mins of 6 mins test by forced swim test relative to control
AID1156227Inhibition of 5-hydroxy[3H]tryptamine uptake at human SERT expressed in African green monkey COS7 cells incubated for 10 mins prior to radioligand addition measured after 5 mins by scintillation counting analysis2014ACS medicinal chemistry letters, Jun-12, Volume: 5, Issue:6
Novel and high affinity fluorescent ligands for the serotonin transporter based on (s)-citalopram.
AID539464Solubility of the compound in 0.1 M phosphate buffer at 600 uM at pH 7.4 after 24 hrs by LC/MS/MS analysis2010Bioorganic & medicinal chemistry letters, Dec-15, Volume: 20, Issue:24
Experimental solubility profiling of marketed CNS drugs, exploring solubility limit of CNS discovery candidate.
AID499950Selectivity ratio of Ki for NET in rat brain frontal cortex to Ki for SERT in rat brain stem2010Journal of medicinal chemistry, Aug-26, Volume: 53, Issue:16
Structure-activity relationships for a novel series of citalopram (1-(3-(dimethylamino)propyl)-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-5-carbonitrile) analogues at monoamine transporters.
AID1347154Primary screen GU AMC qHTS for Zika virus inhibitors2020Proceedings of the National Academy of Sciences of the United States of America, 12-08, Volume: 117, Issue:49
Therapeutic candidates for the Zika virus identified by a high-throughput screen for Zika protease inhibitors.
AID1508630Primary qHTS for small molecule stabilizers of the endoplasmic reticulum resident proteome: Secreted ER Calcium Modulated Protein (SERCaMP) assay2021Cell reports, 04-27, Volume: 35, Issue:4
A target-agnostic screen identifies approved drugs to stabilize the endoplasmic reticulum-resident proteome.
AID1346943Human SERT (Monoamine transporter subfamily)2009Bioorganic & medicinal chemistry letters, Oct-01, Volume: 19, Issue:19
Tetrahydrocarbazole-based serotonin reuptake inhibitor/dopamine D2 partial agonists for the potential treatment of schizophrenia.
AID1346943Human SERT (Monoamine transporter subfamily)2016Nature, Apr-21, Volume: 532, Issue:7599
X-ray structures and mechanism of the human serotonin transporter.
AID1159607Screen for inhibitors of RMI FANCM (MM2) intereaction2016Journal of biomolecular screening, Jul, Volume: 21, Issue:6
A High-Throughput Screening Strategy to Identify Protein-Protein Interaction Inhibitors That Block the Fanconi Anemia DNA Repair Pathway.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (216)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's2 (0.93)29.6817
2010's15 (6.94)24.3611
2020's199 (92.13)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials55 (24.89%)5.53%
Reviews14 (6.33%)6.00%
Case Studies6 (2.71%)4.05%
Observational1 (0.45%)0.25%
Other145 (65.61%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (426)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder [NCT01109030]Phase 2/Phase 350 participants (Actual)Interventional2010-04-30Completed
Post Marketing Study of Escitalopram Versus Risperidone for the Treatment of Behavioral and Psychological Symptoms Amongst Alzheimer's Disease Patients [NCT01119638]Phase 440 participants (Actual)Interventional2008-04-30Completed
Effects of Serotonin Transporter Inhibition on the Subjective Response to Psilocybin in Healthy Subjects [NCT03912974]Phase 127 participants (Actual)Interventional2019-07-04Completed
Randomized, 2-way Crossover, Bioequivalence Study of Citalopram Hydrobromide 40 mg Tablets and Celexa 40 mg Tablets Administered as 1 x 40 mg Tablet in Healthy Subjects Under Fed Conditions [NCT01149980]Phase 124 participants (Actual)Interventional2003-10-31Completed
The Effects of Escitalopram on Cytokines in Depressive Patients [NCT01587326]25 participants (Anticipated)Interventional2012-04-30Recruiting
Comparative Effectiveness of Mindfulness-Based Stress Reduction and Pharmacotherapy for Anxiety [NCT03522844]Phase 4276 participants (Actual)Interventional2018-06-18Completed
Antidepressant Effect of Escitalopram: Delay of Onset. Clinical Randomized Double-blinded Study With Three Parallel Treatment Groups (Escitalopram 20mg vs Escitalopram 30mg vs Escitalopram 20 mg + Pindolol 15 mg/Day [NCT01219686]Phase 2/Phase 318 participants (Actual)Interventional2010-10-31Terminated(stopped due to Recruitment difficulties)
Potential Predictive Biological Markers of Major Depression Response to Citalopram Therapy in Patients With Anorexia Nervosa: a Single-center Study. [NCT05795283]123 participants (Anticipated)Observational2022-08-01Recruiting
A Double-blind, Randomised, Multicenter, Comparative Study of Escitalopram and Duloxetine in Outpatients With Major Depressive Disorder [NCT01148472]Phase 4294 participants (Actual)Interventional2005-09-30Completed
Efficacy of Escitalopram Treatment in Acute Stroke and the Role of SERT Genotype in Stroke [NCT01561092]Phase 40 participants (Actual)InterventionalWithdrawn(stopped due to Study medication could not be supplied. An alternative project will be conducted)
Comparison of Tianeptine Versus Escitalopram for the Treatment of Depression and Cognitive Impairment in Patients With Major Depressive Disorder: A Randomized, Multicenter, Open-label Study [NCT01309776]Phase 4164 participants (Actual)Interventional2011-03-31Completed
SAM-e Treatment of Depression in Parkinson's Disease. [NCT00070941]Phase 2/Phase 329 participants (Actual)Interventional2003-07-31Completed
Combining a Dopamine Agonist and Selective Serotonin Reuptake Inhibitor for Treatment of Depression: A Double-Blind, Randomized Study [NCT00086307]Phase 239 participants (Actual)Interventional2004-06-30Completed
Neural, Genetic, and Peripheral Correlates of SSRI Pharmaco-Response [NCT01251471]Phase 426 participants (Actual)Interventional2011-08-31Completed
EEG Signal Processing as a Predictor of Antidepressant Response [NCT01369290]150 participants (Anticipated)Observational2009-10-31Recruiting
Chinese Longitudinal and Systematic Study of Bioplar Disorder [NCT05480150]10,000 participants (Anticipated)Interventional2021-11-01Recruiting
Fase III Study to Evaluate the Efficacy of LABCAT TCJUSS in Patients With Depressive Episode [NCT02532660]Phase 3111 participants (Actual)Interventional2018-07-02Terminated(stopped due to Recruitment difficulties due to monocentric study)
Clinical Psychopharmacology Division,Institute of Mental Health,Peking University [NCT03148522]120 participants (Anticipated)Interventional2017-06-01Recruiting
Promoting Enhanced Pharmacotherapy Choice Through Immunomarkers Evaluation in Depression [NCT03993457]Phase 418 participants (Actual)Interventional2019-07-23Terminated(stopped due to terminated during COVID due to inability to see participants in person.)
Interventional, Randomised, Double-blind, Placebo-controlled, Active Comparator, Four-way Crossover Electroencephalography Study Investigating the Effects of Vortioxetine (Lu AA21004) in Healthy Male Subjects [NCT02072278]Phase 132 participants (Actual)Interventional2014-02-28Completed
[NCT00149825]Phase 230 participants (Actual)Interventional2004-06-30Completed
Maintenance Therapies in Late-Life Depression: MTLD III [NCT00177671]Phase 4220 participants (Actual)Interventional2003-12-31Completed
Effect of Attention Training or SSRIs on Symptoms and Neural Activation in Social Anxiety [NCT03346239]105 participants (Actual)Interventional2018-07-20Completed
Escitalopram and Language Intervention for Subacute Aphasia (ELISA) [NCT03843463]Phase 288 participants (Anticipated)Interventional2021-07-18Recruiting
Study of Neural Responses Induced by Simulated Antidepressants [NCT02674529]Phase 2/Phase 360 participants (Actual)Interventional2016-09-30Completed
Effect of a Combination of Daclatasvir, Asunaprevir, and BMS-791325 on the Pharmacokinetics of Selective Serotonin Reuptake Inhibitors in Healthy Subjects [NCT02175602]Phase 141 participants (Actual)Interventional2014-06-30Completed
Study on the Effect of PRKCB1 Modulating Inflammatory Factors and the Role for Developing Major Depressive Disorder [NCT03899194]350 participants (Anticipated)Interventional2019-01-01Recruiting
Study of the Efficacy and Safety of Escitalopram for the Prevention of Depressive Episodes Induced by Peg-Interferon Alpha2a and Ribavirin in Chronic Hepatitis C Patients. Randomized, Double-Blind, Placebo-Controlled Clinical Trial [NCT00166296]Phase 2133 participants (Actual)Interventional2005-03-31Completed
Cipralex® for Anxiety Disorders in Adolescents: Clinical and Physiological Changes Associated With Open Label, Flexible-dose Treatment [NCT01293838]Phase 130 participants (Anticipated)Interventional2008-03-31Recruiting
A Randomized, Double-Blind, Active-Controlled, International, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Flexibly-dosed Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New S [NCT03852160]Phase 30 participants (Actual)Interventional2019-12-01Withdrawn(stopped due to New design was developed to better fit company strategy, a new study has replaced 5413541TRD3011 study)
The Changes in Functional Recovery and Brain Neurotrophic Factor Six Months After Percutaneous Coronary Intervention in Cardiovascular Patients With Depression [NCT03841474]150 participants (Anticipated)Interventional2021-03-01Recruiting
The Role of Serotonin in Compulsive Behavior in Humans: Underlying Brain Mechanisms [NCT04336228]Phase 448 participants (Anticipated)Interventional2020-04-01Recruiting
A Phase I, Open-label, Randomized, 3-way Crossover Trial in Healthy Subjects to Investigate the Pharmacokinetic Interaction Between TMC435 and Escitalopram at Steady-state [NCT01090700]Phase 120 participants (Actual)Interventional2010-05-31Completed
A Multicenter, Randomized, Double-Blind, Active Controlled, Comparative, Fixed-Dose, Dose Response Study of the Efficacy and Safety of BMS-820836 in Patients With Treatment Resistant Major Depression (TRD). [NCT01369095]Phase 2976 participants (Actual)Interventional2011-07-31Completed
A Multi-Center, Double Blind, Randomized, Placebo-Controlled, Parallel Group, Flexible Dose Titration, Add-On Study of TC-5214 in the Treatment of MDD With Subjects Who Are Partial Responders or Non-Responders to Citalopram Therapy [NCT00692445]Phase 2574 participants (Actual)Interventional2008-06-30Completed
Anxiety and Depression in Epilepsy: A Pilot Epileptologist-Driven Treatment Study [NCT03522987]Phase 40 participants (Actual)Interventional2018-05-31Withdrawn(stopped due to Decided not to perform the pilot phase)
A Prediction Study of Multiple Indexes of the Effect of Different Mechanisms of Antidepressants Treatment on Depression [NCT03623711]Early Phase 1200 participants (Anticipated)Interventional2018-08-01Recruiting
A Randomized, Double-blind, Multicenter, Active-Controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression [NCT02493868]Phase 3719 participants (Actual)Interventional2015-10-01Completed
Exercise and Pharmacotherapy for Anxiety in Cardiac Patients [NCT02516332]128 participants (Actual)Interventional2015-12-31Completed
Psilocybin vs Escitalopram for Major Depressive Disorder: Comparative Mechanisms [NCT03429075]Phase 259 participants (Actual)Interventional2019-01-07Active, not recruiting
A Multicenter, 52-week, Open-label Study to Assess the Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder [NCT01123707]Phase 3173 participants (Actual)Interventional2010-11-18Terminated(stopped due to The study was terminated early due to Sponsor decision; no safety issues.)
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants [NCT03511118]1,600 participants (Anticipated)Observational2018-10-04Recruiting
An Eight-week, Multinational, Multicenter, Randomized, Double-blind, Placebo-controlled Study, With Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Elderly Patients With Major [NCT00415142]Phase 3393 participants (Actual)Interventional2006-12-31Completed
Escitalopram (Lexapro) for the Treatment of TBI Depression and Other Comorbid Psychiatric Conditions [NCT01368432]Phase 216 participants (Actual)Interventional2010-04-30Completed
A Randomized, Parallel-group,Placebo-controlled, Double-blind Clinical Trial to Evaluate the Efficacy and Safety of Ethosuximide in Chinese Patients With Treatment-Resistant Depression. [NCT03887624]Early Phase 116 participants (Actual)Interventional2019-05-21Terminated(stopped due to Participates could not stand the side effects)
Optimizing Antidepressant Treatment by Genotype-dependent Adjustment of Medication According to the ABCB1 Gene [NCT02237937]Phase 480 participants (Anticipated)Interventional2011-09-30Recruiting
A Phase IIa Multicenter, Randomized, Double-blind, Double-dummy, and Placebo- and Active Controlled Study to Investigate the Safety and Efficacy of JNJ-18038683 Administered to Subjects With Major Depressive Disorder [NCT00566202]Phase 267 participants (Actual)Interventional2007-12-31Completed
Utility of Plasma Drug Level Monitoring and CYP2C19 Genotyping in Dose Personalization of Escitalopram [NCT05210140]148 participants (Anticipated)Observational2020-07-16Recruiting
Biomarkers for Outcomes In Late-life Depression [NCT01082237]Phase 480 participants (Actual)Interventional2009-10-31Completed
Mood Stabilizer Plus Antidepressant Versus Mood Stabilizer Plus Placebo in the Maintenance Treatment of Bipolar Disorder [NCT00958633]Phase 3178 participants (Actual)Interventional2010-11-30Completed
Blood Oxygen Level Dependent (BOLD) Responses During Emotional and Cognitive Processing in Dysphoric and Non-dysphoric Participants and Their Modulation by a Pharmacological Probe of Serotonin Function [NCT01101685]Phase 4160 participants (Anticipated)Interventional2010-02-28Completed
An Eight-week, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Saredutant 100 mg Once Daily in Combination With Escitalopram 10 mg Once Daily in Patients With Major Depressive Disorder [NCT00531622]Phase 3643 participants (Actual)Interventional2007-09-30Completed
Drugs in Breast Milk [NCT05543122]304 participants (Anticipated)Observational2022-03-09Recruiting
An Eight-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study, With Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Patients With Generalized Anxiety Disorder [NCT00417118]Phase 3365 participants (Actual)Interventional2006-12-31Completed
A Multi-Centre, Double-Blind, Randomised, Parallel Group, Escitalopram Controlled Phase III-B Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR TM) as Monotherapy in the Treatment of Adult Patients With Agitated Major D [NCT01363310]Phase 3250 participants (Anticipated)Interventional2010-10-31Terminated(stopped due to Termination of sponsorship)
Serotonin-norepinephrine Reuptake Inhibitors and Acute Kidney Injury [NCT02320240]3,255,526 participants (Actual)Observational2013-06-30Completed
Double-Blind Randomised Investigation of Tibolone or Escitalopram in First Onset Perimenopausal Depression [NCT01368068]Phase 42 participants (Actual)Interventional2012-07-31Terminated(stopped due to Difficulty in recruiting)
A Double-blind, Controlled, Randomized Study Comparing Escitalopram Combined With Scopolamine or Escitalopram in Patients With Major Depressive Disorder [NCT03131050]Phase 466 participants (Actual)Interventional2017-03-15Completed
Randomized, 2-way Crossover, Bioequivalence Study of Citalopram Hydrobromide 40 mg Tablets and Celexa 40 mg Tablets Administered as 1 x 40 mg Tablet in Healthy Subjects Under Fasting Conditions [NCT01149967]Phase 124 participants (Actual)Interventional2003-10-31Completed
Adherence to Antidepressant Treatment in Subjects With Depression [NCT03388164]Phase 223 participants (Actual)Interventional2018-01-01Terminated(stopped due to The study was terminated early based on the planned interim analysis that did not meet criteria for continuation.)
SSRI Effects on Depression and Immunity in HIV/AIDS [NCT02620150]Phase 4108 participants (Actual)Interventional2017-02-16Completed
Sensation and Psychiatry: Linking Age-Related Hearing Loss to Late-Life Depression and Cognitive Decline [NCT03321006]Phase 425 participants (Actual)Interventional2018-05-30Completed
The Effect and Reliability of Escitalopram in the Treatment of Adolescents With Major Depressive Disorder or Anxiety Disorders [NCT03122158]Phase 460 participants (Anticipated)Interventional2017-04-08Active, not recruiting
Continuation Electroconvulsive Therapy Associated With Pharmacotherapy Versus Pharmacotherapy Alone for Relapse Prevention in Major Depression. A Clinical, Controlled, Prospective and Randomized Trial [NCT01305707]Phase 4104 participants (Actual)Interventional2009-07-31Terminated(stopped due to Difficulties in recruiting)
Anxiety and Depression in Epilepsy: A Pilot Epileptologist-Driven Treatment Study [NCT03464383]Phase 469 participants (Actual)Interventional2018-05-07Completed
A Pilot Study Utilizing Escitalopram to Address Cognitive Dysfunction in Glioma Patients [NCT03728673]Phase 220 participants (Anticipated)Interventional2019-03-06Recruiting
Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - a 24 Weeks Double Blind RCT. [NCT00594269]Phase 4149 participants (Actual)Interventional2008-08-31Completed
A Phase II, Multi-center, Randomized, Double-bind, Double-dummy, Active and Placebo Controlled, Parallel Group Study to Assess the Efficacy and Safety of AZD7268 in Patients With Major Depressive Disorder [NCT01020799]Phase 2247 participants (Actual)Interventional2009-11-30Completed
A Randomized Clinical Trial of Response to Psychopharmacotherapy According to Multimodal Serum Biomarkers in Depressive Patients [NCT06054321]400 participants (Anticipated)Interventional2022-08-03Recruiting
Stress and Inflammation in the Pathophysiology of Late Life Depression [NCT02389465]Phase 4119 participants (Actual)Interventional2014-08-31Completed
ERPs, Cognitive Dysfunction and Treatment Response of Geriatric Depression [NCT00754936]106 participants (Actual)Interventional2007-05-31Completed
Post-marketing, Twelve Weeks, Open Label Study of up to 40 mg. Escitalopram in Chronic PTSD [NCT00736021]38 participants (Actual)Interventional2008-09-30Completed
The Role of PKC Activation in the Immune-inflammatory Mechanism of Major Depressive Depression [NCT04156425]180 participants (Anticipated)Interventional2020-07-01Not yet recruiting
Imaging Antidepressant vs. Cognitive Behavior Therapy Effects on Unipolar Depression [NCT00787501]Phase 198 participants (Actual)Interventional2008-06-30Completed
Efficacy and Safety of Escitalopram in Patients With Generalized Anxiety Disorder; Open-label, One Arm Postmarketing Study in Russia [NCT00902564]Phase 430 participants (Actual)Interventional2009-03-31Completed
Escitalopram for the Treatment of Postpartum Depression [NCT00833469]Phase 47 participants (Actual)Interventional2009-01-31Completed
A Randomized Double-blind Parallel Innovator-Controlled Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Generic Escitalopram Oxalate Tablets in the Treatment of Chinese Patients With Depression [NCT00866593]Phase 2/Phase 3260 participants (Actual)Interventional2009-03-31Completed
Intramuscular Ketamine Versus Escitalopram and Aripiprazole in Acute and Maintenance Treatment of Patients With Treatment-resistant Depression [NCT04234776]Phase 488 participants (Anticipated)Interventional2018-04-03Enrolling by invitation
Effect of Selective Serotonin Reuptake Inhibitor on Satiety Function in Patients With Functional Dyspepsia [NCT02153567]Phase 371 participants (Actual)Interventional2013-12-06Completed
Escitalopram Treatment of Major Depression in Patients With Temporal Lobe Epilepsy. A Double-blind, Placebo-controlled Study. [NCT00595699]Phase 48 participants (Actual)Interventional2006-11-30Completed
The Chinese Herb SZ-05 for the Treatment of Depression and Anxiety Disorders; Efficiency, Safety and Biological Correlates [NCT03323697]Phase 1/Phase 260 participants (Anticipated)Interventional2017-08-28Recruiting
Clinical Psychopharmacology Division [NCT03294525]400 participants (Anticipated)Observational2016-01-31Recruiting
An Open-label, Single Dosing Clinical Trial to Investigate the Pharmacokinetics and the Effect on ECG of Escitalopram After Oral Administration in Elderly Volunteers [NCT02122939]Phase 112 participants (Actual)Interventional2013-09-30Completed
Biomarkers of Antidepressant Response and Suicidal Events in Depressed Youth [NCT03547219]152 participants (Actual)Interventional2015-08-05Completed
Double-blind, Randomized, Placebo-Controlled Pilot Study of the Phosphodiesterase-3 Inhibitor Cilostazol as an Adjunctive to Antidepressants in Patients With Major Depressive Disorder [NCT04069819]80 participants (Actual)Interventional2019-08-01Completed
A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Subjects With Treatment-resistant Depression [NCT02422186]Phase 3139 participants (Actual)Interventional2015-08-20Completed
Pentoxifylline as a New Adjuvant in Adult Patients With Major Depressive Disorder: Randomized, Double Blind, Placebo Controlled Trial. [NCT03554447]80 participants (Actual)Interventional2015-04-20Completed
Serum Concentrations of Antidepressant Drugs in Pregnant Women - a Naturalistic Study [NCT04806230]81 participants (Actual)Observational2011-04-01Completed
Efficacy and Safety of Electroacupuncture on Treating the First Episode of Mild to Moderate Depression [NCT05818735]204 participants (Anticipated)Interventional2023-12-01Recruiting
A Pilot Study to Evaluate the Feasibility and Safety of Performing a Double Blind, Placebo-controlled, Randomized Controlled Trial of the Routine Use of SSRI's at the Initiation of End-stage Renal Disease Treatment [NCT02407821]Phase 225 participants (Actual)Interventional2015-03-31Terminated(stopped due to Poor enrolment)
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Trial to Assess the Efficacy, Safety, and Tolerability of Centanafadine Extended-release Capsules as Monotherapy or as Adjunct to SSRI in Adult Subjects With Major Depressi [NCT05536414]Phase 2336 participants (Anticipated)Interventional2022-09-12Recruiting
A Randomized, Single Dose, Open Label, Bioequivalence Study Comparing Citalopram Hydrobromide Tablets 40 mg (Torrent Pharmaceuticals Ltd) and RLD Tablets 40 mg (Manufactured By Forest Pharmaceuticals Inc, Missouri) in 24+2 Normal Healthy Male Subjects Und [NCT00940238]Phase 10 participants InterventionalCompleted
Development of Escitalopram Genomic Device by Using Candidate Gene Approach and Genome-Wide Scanning [NCT00935246]202 participants (Anticipated)Interventional2008-12-31Active, not recruiting
Assessment of PACAP-BDNF Signaling System Involvement in Etiology and Treatment of Major Depression [NCT00944996]100 participants (Actual)Interventional2009-06-30Completed
Impact of Quetiapine Prolong and Escitalopram on the Hypothalamic-pituitary-adrenocortical (HPA)-Axis Activity in Depressed Patients [NCT00953108]Phase 360 participants (Actual)Interventional2009-09-30Completed
A Study of the Effects of LY2216684, a Selective Norepinephrine Reuptake Inhibitor (NERI), in the Treatment of Major Depression [NCT00420004]Phase 2469 participants (Actual)Interventional2006-12-31Completed
Investigation of Genetic Predictors of the Response to SSRI Treatment [NCT03927950]Phase 4135 participants (Actual)Interventional2007-01-31Completed
Double-Blind Placebo-Controlled Study of Escitalopram in the Treatment of Dysthymic Disorder [NCT00220701]Phase 436 participants (Actual)Interventional2002-06-30Completed
Anterior Cingulate Activation in Geriatric Depression [NCT00926653]76 participants (Actual)Observational2005-07-31Completed
A Randomized, Single Dose, Open Label, Bioequivalence Study Comparing Citalopram Hydrobromide Tablets 40 mg (Torrent Pharmaceuticals Ltd) and RLD Tablets 40 mg (Manufactured By Forest Pharmaceuticals Inc, Missouri) in 24+2 Normal Healthy Male Subjects in [NCT00939835]Phase 10 participants InterventionalCompleted
Pharmacodynamics and Pharmacokinetics of Citalopram and Escitalopram [NCT00613470]Phase 1927 participants (Actual)Interventional2005-03-31Completed
Enhancement of Learning Associated Neural Plasticity by Selective Serotonin Reuptake Inhibitors [NCT02753738]Phase 480 participants (Anticipated)Interventional2016-08-31Not yet recruiting
Developing New Clinical Management Strategies for Antidepressant Treatments [NCT03812588]Phase 429 participants (Actual)Interventional2019-01-30Completed
The Objective of This Study Was to Investigate the Bioequivalence of Mylan's Escitalopram Oxalate 20 mg Tablets to Forest's Lexapro® 20 mg Tablets Following a Single, Oral 20 mg (1 x 20 mg) Dose Administered Under Fasting Conditions. [NCT00648570]Phase 137 participants (Actual)Interventional2004-08-31Completed
Neurofunctional Predictors of Escitalopram Treatment Response in Adolescents With Anxiety [NCT02818751]84 participants (Actual)Interventional2015-05-31Completed
Randomised Clinical Trial Comparing Early Medication Change (EMC) Strategy With Treatment as Usual (TAU) in Patients With Major Depressive Disorder - the EMC Trial [NCT00974155]Phase 4889 participants (Actual)Interventional2009-09-30Completed
International Study to Predict Optimised Treatment - in Depression [NCT00693849]Phase 42,688 participants (Anticipated)Interventional2008-09-30Active, not recruiting
Effects of 3 Months of SSRI-Treatment on Metabolism and HPA-axis in Young Men Born With Low Birth Weight - a Randomized, Double Blinded and Placebo-controlled Trial [NCT00971815]60 participants (Actual)Interventional2009-05-31Completed
The Effect of SSRI Treatment on Affective Symptoms and Fertility Treatment Outcome in Women Undergoing In Vitro Fertilization for Unexplained Infertility - a Prospective Placebo-Controlled Study. [NCT00989053]120 participants (Anticipated)Interventional2010-01-31Not yet recruiting
Responses of Myocardial Ischemia to Escitalopram Treatment (REMIT Trial) [NCT00574847]Phase 4127 participants (Actual)Interventional2006-09-30Completed
Single Dose Crossover Comparative Bioavailability Study of Citalopram 40 mg Tablets in Healthy Male Volunteers/Fasting State [NCT00865085]Phase 128 participants (Actual)Interventional2003-06-30Completed
A Relative Bioavailability of 10 mg Citalopram Hydrobromide Tablets Under Fasting Conditions [NCT00865943]Phase 126 participants (Actual)Interventional2003-07-31Completed
Neuroprotective/Neurotrophic Effect of Lexapro® in Patients With Posttraumatic Stress Disorder [NCT01008098]Phase 226 participants (Anticipated)Interventional2008-11-30Recruiting
Combining Antidepressants to Hasten Remission From Depression [NCT00519428]Phase 4245 participants (Actual)Interventional2007-08-31Completed
A Phase IV, Longitudinal, Observational Study Examining Real-World Outcomes of Non-Hormonal Pharmacotherapies Among Individuals Treated for Bothersome Vasomotor Symptoms [NCT06049797]1,000 participants (Anticipated)Observational2023-11-15Recruiting
A Phase 3, Randomized, Double-Blind Study Comparing the Efficacy and Safety of SAGE-217 Plus an Antidepressant Versus Placebo Plus an Antidepressant in Adults With Major Depressive Disorder [NCT04476030]Phase 3440 participants (Actual)Interventional2020-11-09Completed
[NCT00935675]Phase 3100 participants (Anticipated)InterventionalRecruiting
Randomized, Observer-blind, Placebo-controlled, Four-way Cross-over Study to Study the Ability of Functional Magnetic Resonance Imaging (fMRI) of the Brain to Detect and Characterize the Effects of Single Doses of a Selective Serotonin Reuptake Inhibitor [NCT01045083]Phase 125 participants (Actual)Interventional2010-01-31Completed
Open Trial of Escitalopram Treatment for Male Subjects With Posttraumatic Stress Disorder [NCT01024140]16 participants (Actual)Interventional2003-02-28Completed
Imaging Predictors of Treatment Response in Depression [NCT00367341]82 participants (Actual)Interventional2006-08-31Completed
A Double-Blind, Placebo-Controlled Study of the Alternative Therapy S-Adenosyl-L-Methionine (SAMe) vs Escitalopram in Major Depressive Disorder (MDD) [NCT00101452]199 participants (Actual)Interventional2005-04-30Completed
Behavioral Insomnia Therapy For Those With Insomnia and Depression [NCT00620789]477 participants (Anticipated)Interventional2008-03-31Recruiting
Comparison of Two Different Treatment Strategies in Patients With Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy [NCT00810069]Phase 4840 participants (Actual)Interventional2008-11-30Completed
Escitalopram in the Treatment of Patients With Agitated Dementia [NCT00260624]Phase 420 participants (Anticipated)Interventional2003-02-28Completed
Escitalopram Treatment of Major Depression in Diabetes Mellitus: An Open Label [NCT00650897]Phase 430 participants (Anticipated)Interventional2008-04-30Not yet recruiting
Treatment With Escitalopram (Cipralex®) for Adolescents With Obsessive-Compulsive Disorder: Efficacy, Safety, and Changes in Executive Functions, Metacognition, and Regional Brain Activations. [NCT00708240]Phase 440 participants (Anticipated)Interventional2007-01-31Recruiting
[NCT00708396]Phase 420 participants (Anticipated)Interventional2008-07-31Recruiting
Phase IIa Proof of Concept Study of Pipamperone/Citalopram (PipCit) Versus Citalopram in the Treatment of Major Depressive Disorder (MDD) [NCT00672659]Phase 2165 participants (Actual)Interventional2008-02-29Completed
Randomised, Double-Blind, Parallel-Group, Placebo-Controlled, Fixed-Dose Study of Escitalopram in Combination With Two Fixed Doses of Gaboxadol Compared to Escitalopram in Major Depressive Disorder [NCT00807248]Phase 2490 participants (Actual)Interventional2008-11-30Completed
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder [NCT00797966]Phase 2850 participants (Actual)Interventional2009-05-31Completed
Phase IV Pilot Study to Examine the Efficacy and Safety of Escitalopram in Doses up to 50 mg for the Treatment of Patients With Major Depressive Disorder (MDD). [NCT00785434]Phase 460 participants (Actual)Interventional2008-10-31Completed
Effects of Single Dose Citalopram and Reboxetine on Urethral and Anal Closure Function on Healthy Female Subjects [NCT04097288]Phase 124 participants (Actual)Interventional2019-09-17Completed
A Neuroimaging and Epigenetic Investigation of Antidepressants in Depression [NCT00703742]200 participants (Actual)Interventional2008-06-30Completed
Combination Lexapro and Massage for Treatment in Depression in Older Subjects [NCT00643162]17 participants (Actual)Interventional2006-06-30Terminated(stopped due to Interim analysis indicated recruitment was necessary beyond study capabilities.)
Changes of Cerebral Glucose Metabolism Associated With the Fear Network Activity Before and After 12 Weeks of Escitalpram Treatment in Panic Disorder [NCT00767871]Phase 446 participants (Actual)Interventional2007-03-31Completed
Single-Dose Food In Vivo Bioequivalence Study of Escitalopram Oxalate Tablets (20 mg; Mylan) to Lexapro® Tablets (20 mg; Forest) in Healthy Volunteers [NCT00648661]Phase 135 participants (Actual)Interventional2004-09-30Completed
Dopaminergic Effects of Adjunctive Aripiprazole on the Brain in Treatment-Resistant Depression: A Raclopride/F-DOPA Positron Emission Tomography and Functional MRI Study [NCT00953745]43 participants (Actual)Interventional2009-05-31Completed
Dichotic Listening as a Predictor of Medication Response in Depression [NCT00404755]Phase 417 participants (Actual)Interventional2006-07-31Completed
Eszopiclone Co-Administered With Escitalopram for Insomnia in Elderly Adults With Major Depressive Disorder [NCT00813735]Phase 460 participants (Actual)Interventional2006-09-30Completed
An Eight-week, Multinational, Multicenter, Double-blind, Active- and Placebo-controlled Clinical Trial Evaluating the Efficacy and Tolerability of Three Fixed Doses of SSR125543 (20 mg Daily, 50 mg Daily and 100 mg Daily) in Outpatients With Major Depress [NCT01034995]Phase 2580 participants (Anticipated)Interventional2010-02-28Completed
The Effect of Escitalopram on the Pharmacokinetics and Pharmacodynamics of Tramadol in Healthy Subjects [NCT00692263]Phase 415 participants (Actual)Interventional2008-02-29Completed
The Effect of Escitalopram on Mood, Quality of Life and Cognitive Functioning in Glioblastoma Patients [NCT02623231]Phase 2/Phase 3100 participants (Anticipated)Interventional2015-12-31Not yet recruiting
Changes of Sleep EEG Power and Melatonin Rhythm in Major Depressive Disoder: a Self-controlled, 8 Weeks Study of Treatment With Escitalopram Compared With Healthy Subjects [NCT04013464]31 participants (Actual)Interventional2016-05-01Completed
Brain Mechanisms and Targeting Insomnia in Major Depression [NCT00628914]Phase 460 participants (Anticipated)Interventional2008-05-31Active, not recruiting
Determination of the Circadian Resetting Effects of Escitalopram and Testing for Correlations Between Circadian Resetting and Antidepressant Effects [NCT01214044]19 participants (Actual)Interventional2008-05-31Completed
Using Wearable Devices to Investigate the Basic Physical Conditions of Patients With Sleep Problems and the Physical Effects During Sleep on Patients Who Use the Central Nervous Medications for Sleep Problems [NCT05300386]52 participants (Actual)Observational2018-05-30Completed
Efficacy of Escitalopram in the Treatment of Internet Addiction [NCT00565422]Phase 431 participants (Actual)Interventional2002-12-31Completed
A Single-dose, Open-label, Randomised, Crossover Bioequivalence Study in Healthy Young Men Comparing Two Formulations of Escitalopram [NCT01395433]Phase 132 participants (Actual)Interventional2010-01-31Completed
A Phase II, Randomized, Double-blind, Trial Comparing Escitalopram to Placebo in Patients With Localized Pancreatic Cancer [NCT05289830]Phase 246 participants (Anticipated)Interventional2022-08-05Recruiting
Single Dose Crossover Comparative Bioavailability Study of Citalopram 40 mg Tablets in Healthy Male Volunteers/Fed State [NCT00864890]Phase 132 participants (Actual)Interventional2003-06-30Completed
Effects on Clinical and Functional Outcome of Escitalopram in Adult Stroke [NCT00967408]Phase 4200 participants (Anticipated)Interventional2009-07-31Recruiting
A Phase I, Open-label, Randomized, Crossover Trial in 16 Healthy Subjects to Investigate the Potential Pharmacokinetic Interaction Between Telaprevir and Escitalopram at Steady-state [NCT00933894]Phase 116 participants (Actual)Interventional2009-09-30Completed
SSRIs and Self-harm in Borderline Personality Disorder [NCT01103180]Phase 270 participants (Actual)Interventional2010-09-30Terminated(stopped due to Funding withdrawn due to inability to accrue)
A Pilot Study -- An Open-Label, Rater-blinded, Flexible-dose, 8-week Trial of Escitalopram (Lexapro®) In Patients With Major Depression With Atypical Features. [NCT00610506]Phase 315 participants (Actual)Interventional2005-10-31Completed
Menopause Strategies: Finding Lasting Answers for Symptoms and Health: Efficacy of a Selective Serotonin Reuptake Inhibitor (SSRI) for Menopausal Symptoms in Midlife Women [NCT00894543]205 participants (Actual)Interventional2009-07-31Completed
A Study to Investigate the Effect of Antidepressants on the Treatment for Korean Major Depressive Disorder (MDD) Patients [NCT00926835]Phase 4692 participants (Actual)Interventional2009-05-31Terminated(stopped due to due to patient recruitment difficulties)
Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder, Adherence to Antiretroviral Therapy,Cognition, and Immune Status Among Patients With HIV and AIDS: A 6-week Open-label, Prospective, Pilot Trial. [NCT00887679]Phase 330 participants (Actual)Interventional2009-05-31Completed
IL-2 Neuropsychiatric Symptoms: Mechanism and Prevention [NCT00352885]Phase 420 participants (Actual)Interventional2006-10-06Completed
Blood Levels of Neurosteroids and Neurotrophic Factors in Normal Controls and in Patients With Major Depression [NCT00812994]Phase 430 participants (Actual)Interventional2003-01-31Completed
An Eight-week, Multicenter, Randomized, Double-blind, Placebo-controlled Dose-finding Study, With Escitalopram (10 mg Daily) as Active Control, to Evaluate the Efficacy, Safety and Tolerability of Three Fixed Doses of SSR411298 (10, 50, or 200 mg Daily) i [NCT00822744]Phase 2527 participants (Actual)Interventional2008-12-31Completed
Sinusitis and Facial Pain Disorders Anti-Depression Trial [NCT00754793]Phase 43 participants (Actual)Interventional2009-01-31Terminated(stopped due to poor recruitment)
Differential Responses to Cognitive Behavioural Analysis System of Psychotherapy (CBASP)Versus Escitalopram in Chronic Major Depression With and Without Early Trauma [NCT00837564]Phase 360 participants (Anticipated)Interventional2009-02-28Recruiting
Associations Between Gene-Polymorphisms, Endo-Phenotypes for Depression and Antidepressive Treatment (AGENDA) [NCT00386841]Phase 480 participants (Actual)Interventional2007-04-30Completed
Prevention of Post Traumatic Stress Disorder by Early Treatment [NCT00146900]298 participants (Actual)Interventional2004-08-31Completed
Bariatric Surgery and Pharmacokinetics Escitalopram: BAR-MEDS Escitalopram [NCT03460379]12 participants (Anticipated)Observational2016-11-02Recruiting
Specific Effects of Escitalopram on Neuroendocrine Response [NCT00150527]8 participants (Actual)Observational2005-09-30Completed
The Use of Quantitative EEG (QEEG) as a Predictor of Treatment Outcome in Major Depressive Disorder [NCT00157547]Phase 495 participants (Actual)Interventional2003-04-30Completed
Depression-Diabetes Mechanisms: Urban African Americans [NCT00209170]Phase 420 participants (Actual)Interventional2004-05-31Completed
Symptom Management Trial in Cancer Survivors [NCT00387348]Phase 324 participants (Actual)Interventional2006-03-31Terminated(stopped due to DSMB stopped study because placebo arm had more adverse events)
Serum Brain-Derived Neurotrophic Factor (BDNF) and QEEG as Biological Markers of Response to (Es)Citalopram Treatment in Major Depressive Disorder [NCT00361218]Phase 372 participants (Actual)Interventional2005-10-31Completed
Do Antidepressants Reverse the Effects of Early Life Stress on the Brain and Thrombovascular System and Improve Psychological, Neuroendocrine, and Platelet Function: A Study of Men and Women With Childhood Abuse. [NCT00166114]Phase 440 participants (Actual)Interventional2002-02-28Completed
Efficacy and Tolerability of Escitalopram for the Prevention of Pegylated Interferon Alfa Associated Depression in Patients With Chronic Hepatitis C Infection: a Randomized Controlled Trial. [NCT00136318]Phase 3208 participants (Actual)Interventional2004-01-31Completed
A Double-blind, Randomized, Placebo Controlled Clinical Trial on Comparing Escitalopram and Duloxetine add-on for Negative Symptoms in Schizophrenic Subjects With Neuregulin-1 (NRG1) Risk Genotype [NCT01078870]Phase 475 participants (Anticipated)Interventional2010-02-28Active, not recruiting
A Multicenter, Randomized, Double-Blind, Placebo and Escitalopram Controlled Trial of the Safety and Efficacy of BMS-562086 in the Treatment of Outpatients With Major Depressive Disorder [NCT00135421]Phase 1/Phase 2271 participants (Actual)Interventional2005-11-30Completed
Escitalopram and Transcranial Direct Current Stimulation in Major Depressive Disorder: a Double-blind, Placebo-controlled, Randomized, Non-inferiority Trial [NCT01894815]Phase 3245 participants (Actual)Interventional2013-10-31Completed
Patient Preference in Primary Care Depression Treatment [NCT00194948]60 participants Interventional2003-09-30Completed
Escitalopram vs. Sertraline in the Treatment of Dysthymic Disorder and Double Depression [NCT00234312]Phase 440 participants Interventional2005-09-30Completed
Effect of Escitalopram vs. Reboxetine on Somatic and Visceral Sensitivity of Patients With Major Depressive Disorder: a Randomized, Double Blind Clinical Trial [NCT00209807]Phase 442 participants (Anticipated)Interventional2005-09-30Recruiting
Effects of Escitalopram vs. Duloxetine on Heart Rate Variability and Autonomic Cardiovascular Control [NCT00215228]Phase 2/Phase 326 participants (Anticipated)Interventional2005-07-31Completed
MOTIV Study. Effect of Antidepressive Treatment by Escitalopram Started Preoperatively in Patients Undergoing Coronary Artery Bypass Grafting [NCT00243477]Phase 4368 participants (Actual)Interventional2006-01-31Completed
The Effect of Cipralex in Polycystic Ovary Syndrome [NCT01961180]Phase 442 participants (Actual)Interventional2013-06-30Completed
A 12-Week Randomized, Double-blind, Parallel-group, Placebo-controlled Trial With and Open-label, 12-week Extension, Multicenter to Evaluation of the Efficacy of Escitalopram for the Treatment of Depression in Alzheimer's Disease [NCT01841125]Phase 484 participants (Actual)Interventional2011-11-30Completed
An Open Label, Randomised, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Escitalopram Oxalate Tablet Containing Escitalopram (20mg) [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Lexapro® Tablet (20mg) [Reference Fo [NCT01996462]Phase 10 participants InterventionalCompleted
An Open Label, Randomized, 2-Period, 2-Treatment, Crossover, Single-Dose Bioequivalence Study of Escitalopram Oxalate Tablet 20mg [Test Formulation, Torrent Pharmaceuticals Ltd., India] Versus Lexapro® (Escitalopram Oxalate Tablet 20mg) [Reference Formula [NCT01996475]Phase 10 participants InterventionalCompleted
Phase 4 Study of Escitalopram Treatment and Biomarkers in Major Depressive Disorder [NCT01997580]Phase 4600 participants (Anticipated)Interventional2013-07-31Recruiting
An Open-label, 8- Week, Flexible Dose Trial of Escitalopram (Lexapro®) in Comorbid Major Depression With Amyotrophic Lateral Sclerosis and Multiple Sclerosis [NCT00965497]Phase 313 participants (Actual)Interventional2009-07-31Completed
Effects of Home-based TEA for Abdominal Pain in Patients With Irritable Bowel Syndrome (IBS) [NCT05519683]Phase 2/Phase 3160 participants (Anticipated)Interventional2022-11-02Recruiting
Effects of Bupropion Versus Escitalopram on Reward Circuitry and Motivational Deficits in Patients With Major Depression and Increased Inflammation and Anhedonia [NCT04352101]Phase 418 participants (Actual)Interventional2020-09-23Completed
Randomized Controlled Trial of Treating Rectal Hypersensitivity - Comparing Escitalopram With Sensory Adaptation Training [NCT00584571]Phase 255 participants (Actual)Interventional2007-12-31Completed
Geriatric Depression: Getting Better, Getting Well [NCT00177294]Phase 4319 participants (Actual)Interventional2004-04-30Completed
Psychobiology and Treatment Response in Primary Insomnia [NCT00177216]Phase 469 participants (Actual)Interventional2002-02-28Completed
An Open-label Long-term Study of Escitalopram in Children 7 to 11 Years of Age With Major Depressive Disorder [NCT01198795]Phase 4162 participants (Actual)Interventional2010-09-30Completed
Prevention of Depression in Patients Being Treated for Head and Neck Cancer [NCT00536172]Phase 4160 participants (Actual)Interventional2007-12-01Completed
Combination Therapy With Modafinil and Escitalopram for the Treatment of Cocaine Dependence [NCT01601730]Phase 168 participants (Actual)Interventional2010-08-31Completed
Genetic-pharmacological Neuroimaging of the Serotonergic System in Violent Video Games [NCT01644071]47 participants (Actual)Interventional2012-02-29Completed
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies [NCT02893371]1,037,352 participants (Actual)Observational2016-09-30Completed
Unraveling the Nature of Impaired Pain Inhibition in Patients With Chronic Whiplash-associated Disorders: a Randomized Controlled Clinical Trial for the Treatment of Central Sensitization [NCT01601912]59 participants (Actual)Observational2013-02-28Completed
A Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder [NCT01111552]Phase 3237 participants (Actual)Interventional2010-07-29Terminated(stopped due to The study was terminated early due to Sponsor decision, closure of this combination therapy program is unrelated to any safety issues, no signals of concern.)
An Interventional, Randomised, Double-blind, Parallel-group, Active-comparator, Flexible-dose Study on the Efficacy of Vortioxetine Versus Escitalopram on Cognitive Dysfunction in Patients With Inadequate Response to Current Antidepressant Treatment of Ma [NCT02272517]Phase 3101 participants (Actual)Interventional2014-12-31Completed
A Double-blind Flexible Dose Study of Escitalopram in Pediatric Patients With Major Depressive Disorder [NCT00107120]Phase 3312 participants (Actual)Interventional2005-03-31Completed
Treatment of Marijuana Withdrawal Syndrome Using Escitalopram and Cognitive-Behavior Therapy- a Double-Blind Placebo-Controlled Study [NCT00598052]40 participants (Anticipated)Interventional2007-12-31Recruiting
Comparison of Effects Between Conventional Dose and High Dose Escitalopram on Clinical Improvement in Patients With Obsessive-compulsive Disorder (Randomized, Double-blind, Multi-center Study) [NCT00723060]Phase 4176 participants (Actual)Interventional2008-09-30Completed
Validation of Surrogate Measures in Irritable Bowel Syndrome (IBS) [NCT00693732]Phase 430 participants (Actual)Interventional2009-02-28Completed
Safety and Efficacy of Escitalopram in the Treatment of Premature Ejaculation A Double-Blind, Placebo-Controlled, Fixed-Dose,Randomized Controlled Study [NCT00656552]Early Phase 1100 participants (Anticipated)Interventional2008-05-31Not yet recruiting
The Amplitude Change of the Auditory Evoked N1 Component as a Predictor of Response to Escitalopram Treatment in Patients With Generalized Anxiety Disorder [NCT00613067]35 participants (Anticipated)Interventional2007-12-31Completed
A Comparison of the CNS Effects of Equivalent Doses of Escitalopram and Racemic Citalopram Using BOLD fMRI [NCT00825825]Phase 427 participants (Actual)Interventional2007-05-31Completed
Relapse Prevention in Patients With a Major Depressive Episode Treated With Electroconvulsive Treatment Using a Fixed Dose Range of Escitalopram Compared to a Fixed Dose of Nortriptyline (DUAG-7) A Randomised Controlled 6 Month Double-blind Study [NCT00660062]Phase 447 participants (Actual)Interventional2009-08-31Terminated(stopped due to Slow inclusion)
Escitalopram for Premenstrual Syndrome (PMS) in Teens: A Pilot Study [NCT00523705]Phase 411 participants (Actual)Interventional2008-02-29Terminated(stopped due to Enrollment too slow.)
[NCT02711215]Phase 480 participants (Anticipated)Interventional2015-05-31Active, not recruiting
Predicting Treatment Outcome in Major Depressive Disorder [NCT02869035]Phase 1100 participants (Anticipated)Interventional2016-08-31Completed
The Interest of a Specific Combined Treatment (Psychotherapy and Pharmacotherapy) in Patients With Dissociative Disorders [NCT00630981]30 participants (Actual)Observational2008-02-29Active, not recruiting
Dose-finding Study of Selective Serotonin Reuptake Inhibitors to Enhance Neuroplasticity [NCT04221256]Phase 1/Phase 20 participants (Actual)Interventional2020-03-11Withdrawn(stopped due to Closure due to COVID-19 pandemic)
A Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder [NCT01111539]Phase 3211 participants (Actual)Interventional2010-07-13Terminated(stopped due to The study was terminated early due to Sponsor decision, closure of this combination therapy program is unrelated to any safety issues, no signals of concern.)
CISS: Cortical Ischemic Stroke and Serotonin - Effects of Serotonergic Neuromodulation on Behavioural Recovery and Motor Network Plasticity After Cortical Ischemic Stroke: a Longitudinal, Placebo-controlled Study [NCT02865642]Phase 290 participants (Anticipated)Interventional2016-08-31Recruiting
The Efficacy and Tolerability of Seroquel XR Combined With a Selective Serotonin Re-Uptake Inhibitor Versus Seroquel XR Monotherapy in the Acute Treatment of Major Depressive Disorder With Psychotic Features [NCT00955474]Phase 432 participants (Actual)Interventional2008-09-30Terminated(stopped due to AstraZeneca halted funding; patent expired for Seroquel (Quetiapine) in 2012)
Predicting Medication Response in Obsessive Compulsive Disorder [NCT01404871]26 participants (Actual)Interventional2009-04-30Completed
Neural Mechanisms of Monoaminergic Engagement in Late-life Depression Treatment Response (NEMO) [NCT03128021]Phase 480 participants (Anticipated)Interventional2017-05-24Recruiting
A Study to Investigate the Effect of Multiple Doses of Danoprevir/Ritonavir (DNV/RTV) on the Pharmacokinetics (PK) of Escitalopram (ESC) and S-Demethylcitalopram (S-DCT) in Healthy Subjects [NCT01418274]Phase 120 participants (Actual)Interventional2011-08-31Completed
Personalizing Treatment of Depression Complicated by Panic Features-Pilot Study [NCT00930293]50 participants (Actual)Interventional2009-07-31Completed
Escitalopram as a Treatment for Pain in Polyneuropathy. A Double-Blind, Randomized, Placebo Controlled Trial. [NCT00162968]Phase 450 participants Interventional2004-12-31Completed
Exploring Biomarkers for Depression [NCT01424111]51 participants (Actual)Observational2011-08-31Completed
Analgesic Effect of Perioperative Escitalopram for Patients With High Preoperative Level of Pain Catastrophising in Total Knee Arthroplasty [NCT01430520]Phase 4120 participants (Actual)Interventional2011-09-30Completed
Open Label Variable Dose Escitalopram (Lexapro) in the Treatment of Patients With Postpartum Major Depression: A Pilot Study [NCT00277108]20 participants (Anticipated)Interventional2004-02-29Completed
Leveraging EEG for Antidepressant Prediction With Sertraline and Escitalopram (LEAP-SE): A Multicenter, Randomized, Blinded Outcome Study of EEG-guided Treatment With Sertraline Versus Escitalopram in Adults With Major Depressive Disorder [NCT04388202]Phase 40 participants (Actual)Interventional2020-10-15Withdrawn(stopped due to No participants enrolled)
Game Intervention as Adjunct Therapy for Anhedonia in Patients With Major Depressive Disorder [NCT04977232]50 participants (Anticipated)Interventional2021-09-09Recruiting
Aging White Matter Changes, Executive Dysfunction and Depression [NCT00918684]Phase 4116 participants (Actual)Interventional2002-12-31Completed
Personalized Response Indicators of SSRI Effectiveness in Major Depression [NCT00917059]Phase 4172 participants (Actual)Interventional2009-05-31Completed
A Multicenter, Randomized, 8-Week Double-Blind Acute Phase Followed By a 6-Month Continuation Phase (Open-Label Or Double-Blind) Study to Evaluate the Efficacy, Safety, and Tolerability of DVS SR Versus Escitalopram in Postmenopausal Women With Major Depr [NCT00406640]Phase 3595 participants (Actual)Interventional2006-12-31Completed
A PET Study to Determine Alterations in Serotonin Levels in Human Brain After a Single Dose of Escitalopram [NCT01638689]Phase 110 participants (Actual)Interventional2010-09-30Completed
Clinical Trial to Investigate the Effect on Corrected QT Interval Prolongation by Psychotropic Drugs in Healthy Korean Adults After a Single Oral Administration of Escitalopram, Quetiapine, and Moxifloxacin [NCT01871701]Phase 140 participants (Actual)Interventional2012-11-30Completed
Blood-brain-barrier Permeability of Escitalopram Depending on Genetic Polymorphisms of the ABCB1-gene: Effect on Sleep and Procedural Learning [NCT00550485]79 participants (Actual)Interventional2007-10-31Completed
A Double-Blind, Placebo-Controlled Trial Examining the Efficacy of Escitalopram Oxalate Upon Depressive Symptoms and Fatigue in HIV Seropositive Women [NCT01797380]Phase 45 participants (Actual)Interventional2008-01-31Terminated(stopped due to Failure to recruit.)
Comparison of Aripiprazole Augmentation vs Switching to Different Class of Antidepressants for Patients With MDD Who Are Partially/Minimally Responsive to Current Antidepressants:Randomized, Rater-blinded, Prospective Study [NCT01488266]90 participants (Anticipated)Interventional2011-11-30Active, not recruiting
Multimodal Assessment of Neurobiological Markers for Psychiatric Disorders [NCT01477203]Phase 4289 participants (Actual)Interventional2011-11-30Completed
Functional Neuroimaging in Depression: Longitudinal Study of PET Metabolism in Correlation With Changes in Attentional Bias, Autobiographical Memory, Future Fluency and Facial Recognition in Depressed Patients Treated With Escitalopram. [NCT00343070]Phase 240 participants (Anticipated)Interventional2007-03-31Completed
A Multi-National, Multi-Center, DB, Placebo-Controlled, Parallel Group, Fixed Dose Efficacy & Safety Study of SR58611A 350 mg Twice Daily vs. Placebo in Adults With Major Depressive Disorder on Concomitant Treatment With Escitalopram 10mg/d [NCT00432614]Phase 3510 participants (Actual)Interventional2007-01-31Completed
Discontinuation of Antipsychotics and Antidepressants Among Patients With Dementia and BPSD Living in Nursing Homes - an Open Study. [NCT00433121]Phase 424 participants (Actual)Interventional2006-09-30Completed
Escitalopram and Sleep Architecture in Patients With Major Depressive Disorder [NCT00442481]Phase 425 participants Interventional2007-02-28Recruiting
A Comparative Study on Efficacy and Safety of add-on Sulforaphane or rTMS to Escitalopram for Major Depressive Disorder With Poor Response to Initial Treatment [NCT05145270]Phase 4180 participants (Anticipated)Interventional2019-11-30Recruiting
Comparative Evaluation of Vortioxetine Versus Other Antidepressants With Pregabalin Augmentation in Treatment-resistant Burning Mouth Syndrome: a Prospective Longitudinal Clinical Trial With Treatment Response Prediction [NCT06025474]Phase 3203 participants (Anticipated)Interventional2023-01-01Recruiting
[NCT02934035]10,000 participants (Anticipated)Observational2016-09-30Active, not recruiting
Efficacy and Safety of Escitalopram in Patients With Social Anxiety Disorder; Open-label, One Arm Postmarketing Study in Russia [NCT00902226]Phase 430 participants (Actual)Interventional2009-03-31Completed
A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder, the Orion Trial [NCT01360866]Phase 32,944 participants (Actual)Interventional2011-10-31Completed
Phase Four Double-Blind Randomized Comparative Study on Thestudy on the Efficacy of Memantine Hydrochloride and Escitalopram for the Treatment of Co-Morbid Depression and Alcoholism [NCT00368862]Phase 480 participants Interventional2005-12-31Completed
A Multicenter, Double Blind Trial to Compare the Efficacy and Safety of Escitalopram With Placebo in Patients With Acute Stroke for the Prevention of Poststroke Depression and Related Symptoms (Emotional Incontinence, Anger Proneness), and for Improvement [NCT01278498]Phase 4444 participants (Anticipated)Interventional2011-01-31Active, not recruiting
Randomized, Double Blind, Efficacy Study of Escitalopram Versus Placebo in ENT Cancer Patients Suffering From Emotional Distress [NCT02246244]Phase 338 participants (Actual)Interventional2009-04-30Completed
A Randomised Trial Investigating the Cardiovascular Effects of Agomelatine and Escitalopram in Patients With Major Depressive Disorder. [NCT01483053]Phase 440 participants (Anticipated)Interventional2014-01-31Not yet recruiting
Exploratory Study to Assess the Efficacy of Escitalopram Versus Placebo in the Treatment of Depressive Syndrome in Alzheimer's Disease, Vascular Dementia and Mixed Vascular and Alzheimer's Dementia [NCT00229333]Phase 440 participants Interventional2004-12-31Recruiting
Depression: The Search for Treatment-Relevant Phenotypes [NCT00073697]Phase 4290 participants (Actual)Interventional2003-05-31Completed
Development and a Pilot Study of the PACEPRO Exercise and Mood Management Program in Depressed Patients on Escitalopram Oxalate (Lexapro) [NCT00416221]40 participants (Actual)Interventional2006-04-30Completed
Fixed Dose Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder [NCT00109044]Phase 3540 participants Interventional2005-03-31Completed
[NCT00300313]450 participants (Anticipated)Interventional2005-06-30Completed
Phase III Open Study of High Dose Escitalopram for the Treatment of Obsessive-Compulsive Disorder in Adults [NCT00305500]Phase 3100 participants Interventional2006-03-31Completed
Galantamine Augmentation of Escitalopram for Treatment of Depression Associated Cognitive Impairment in Outpatients - A Randomized Single Blind Clinical Trial [NCT00423969]Phase 420 participants Interventional2003-11-30Terminated
Comparative Responses to 15 Different Antidepressants in Major Depressive Disorder - Results From a Long-term Nation-wide Population-based Study Emulating a Randomized Trial [NCT05952713]73,336 participants (Actual)Observational2022-10-01Completed
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Controlled Study of the Efficacy and Safety of Sustained-Release Quetiapine Fumarate (SEROQUEL®) Compared With Placebo in the Treatment of Generalized Anxiety Disorder [NCT00329446]Phase 3800 participants (Anticipated)Interventional2006-04-30Completed
Citalopram Treatment in Children With Autism Spectrum Disorders and High Levels of Repetitive Behavior [NCT00086645]Phase 2149 participants (Actual)Interventional2004-04-30Completed
Pharmacotherapy of Late-Life Generalized Anxiety Disorder [NCT00105586]Phase 4177 participants (Actual)Interventional2004-12-31Completed
Serotonin Transporter Genetic Variation and Amygdalar Activation Correlates of Antidepressant Response [NCT00456430]Phase 480 participants (Anticipated)Interventional2003-07-31Completed
Escitalopram in the Treatment of Patient Suffering From Scizophrenia and Obsessive Compulsive Disorder- an Open Label Study [NCT00456937]Phase 415 participants (Anticipated)Interventional2006-07-31Completed
A Multi-Centre, Double-Blind, Randomised, Parallel Group, Placebo- Controlled and Active Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) as Mono- Therapy in the Treatment of Adult Patients Wit [NCT00351169]Phase 3450 participants (Anticipated)Interventional2006-05-31Completed
A Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained Release (Seroquel SRTM) in Combination With an Antidepressant in the Treatment of Patients With Major [NCT00351910]Phase 3494 participants (Actual)Interventional2006-05-31Completed
SSRI Administration to Reduce Acute Stress Disorder Symptoms and Prevent Depression and Posttraumatic Stress Disorder in Physical Trauma Victims in the Medical Setting [NCT00114374]Phase 360 participants (Anticipated)Interventional2005-06-30Terminated
Escitalopram in Bipolar Depression: a Placebo-controlled Study of Acute and Maintenance Treatment [NCT00464191]Phase 4150 participants (Anticipated)Interventional2006-04-30Terminated(stopped due to The study has been terminated because too few patients have been recruited)
Escitalopram for the Treatment of Obsessive Compulsive Disorder [NCT00116532]Phase 430 participants Interventional2002-10-31Completed
Antidepressants During Office-Based Buprenorphine [NCT00475878]Phase 3147 participants (Actual)Interventional2006-12-31Completed
Brain GABA Levels and Treatment Response in Major Depressive Disorder [NCT00464711]Phase 440 participants (Actual)Interventional2006-09-30Completed
Lexapro for Major Depression in Patients With Epilepsy [NCT01244724]Phase 426 participants (Actual)Interventional2007-10-31Terminated(stopped due to Unable to recruit targeted #)
Effects of Escitalopram on Autonomic Reactivity in Post Traumatic Stress Disorder Among Veterans of Operation Enduring Freedom and Iraqi Freedom (OEF/OIF) [NCT01271244]Phase 426 participants (Actual)Interventional2008-06-30Completed
Escitalopram for the Treatment of Self-Injurious Skin Picking [NCT00115011]Phase 430 participants (Actual)Interventional2002-09-30Completed
The Effects of Increased Central Serotonergic Activity on Psychophysiological Parameters of Human Information Processing [NCT00206934]40 participants (Actual)Interventional2005-03-31Completed
Multi-center, Randomized, Placebo-controlled, Double-blind Clinical Trial of Escitalopram on the Progression Delaying Effect in Alzheimer's Disease [NCT00702780]74 participants (Actual)Interventional2008-11-30Completed
Cipralex in Treatment of Depressive Symptoms and Chronic Back Pain [NCT00227292]Phase 40 participants (Actual)Interventional2007-11-30Withdrawn(stopped due to Mutual agreement between Sponsor and Investigator.)
An Open-label Study of Escitalopram in the Treatment of Major Depressive Disorder in Elderly Patients With Alzheimer's Disease [NCT00488670]Phase 350 participants (Anticipated)Interventional2010-12-31Terminated(stopped due to Dr. Rabheru left VCH last year and the study was cancelled according to his research coordinator.)
Changes in the Vasodilatory Response to Methyl-nicotinate in Response to S-citalopram Treatment in Social Phobia Patients [NCT00485888]Phase 271 participants (Actual)Interventional2008-10-31Completed
The Role of Childhood Adversity and Genetic Polymorphisms in the Serotonin and Brain-Derived Neurotrophic Factor Systems in the Sensitization to Stress in First-Onset Major Depression (Blue Sky Project) [NCT00517764]299 participants (Actual)Interventional2006-12-31Completed
An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression [NCT02497287]Phase 3802 participants (Actual)Interventional2015-09-30Completed
The Effect of Escitalopram on Exacerbation Rates and Quality of Life in Patients With Anxiety Associated With Severe COPD [NCT01522092]Phase 30 participants (Actual)InterventionalWithdrawn(stopped due to Study was not given ethical approval- a alternative protocol required)
A Randomised, Controlled Trial to Investigate the Effect of a Six Week Intensified Pharmacological Treatment for Bipolar Depression Compared to Treatment as Usual in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment. [NCT05973786]Phase 4418 participants (Anticipated)Interventional2023-11-01Not yet recruiting
The Effect of Antidepressants and Gabapentin on Tamoxifen Pharmacokinetics: A Prospective Study [NCT00667121]85 participants (Anticipated)Observational2011-03-16Active, not recruiting
Pharmacotherapy Dosing Regimen in Cocaine and Opiate Dependent Individuals [NCT00218036]Phase 254 participants (Actual)Interventional2006-07-31Terminated(stopped due to PI left institution, end of funding, clinic relocation, recruitment issues)
An Open-label Study of Escitalopram in the Treatment of Postpartum Depression [NCT01527474]20 participants (Actual)Interventional2008-04-30Completed
Molecular Markers of Neuroplasticity During High-Intensity Exercise in Subjects With Incomplete Spinal Cord Injury [NCT01538693]30 participants (Anticipated)Interventional2011-12-31Completed
Neuroimaging Study of Bupropion Treatment in Patients With Major Depressive Disorder [NCT01541475]Phase 460 participants (Actual)Interventional2009-03-31Completed
Randomized Controlled Trial of Escitalopram Versus Placebo for Patients With Irritable Bowel Syndrome and Panic Disorder [NCT01551225]Phase 432 participants (Actual)Interventional2012-01-31Completed
The Effect of Anti Depressive Medicine on Adrenal Activity, Glucose Metabolism, Physical and Mental Health in Polycystic Ovary Syndrome. -A Randomised, Double Blinded, Placebo Controlled Study. [NCT05840692]Phase 440 participants (Actual)Interventional2013-08-31Completed
Double-Blind Study of Escitalopram in Adult Patients With Major Depressive Disorder [NCT00108979]Phase 3240 participants Interventional2005-03-31Completed
Placebo-Controlled Pilot Study of Escitalopram in the Treatment of Specific Phobia [NCT00121069]Phase 2/Phase 312 participants Interventional2002-09-30Completed
Sertraline Versus Escitalopram in South Asian Participants With Moderate to Severe Major Depressive Disorder: A Double-blind, Parallel, Randomized Controlled Trial [NCT05950061]Phase 3744 participants (Actual)Interventional2022-06-01Completed
Duloxetine Versus Escitalopram and Placebo in the Treatment of Patients With Major Depression [NCT00073411]Phase 3675 participants Interventional2003-11-30Completed
[NCT00080158]Phase 2/Phase 3120 participants Interventional2004-03-31Completed
A Double-Blind, Placebo-Controlled Study of Escitalopram in the Prevention of Depression in Patients With Acute Coronary Syndrome [NCT00140257]Phase 4240 participants (Actual)Interventional2004-11-30Active, not recruiting
A 12 Week Multi-Centre, Randomized, Double-Blind, Placebo Controlled Evaluation of the Most Efficacious and Tolerable Dose of Escitalopram in the Treatment of Elderly Patients [NCT00130455]Phase 4189 participants Interventional2006-04-30Terminated
Pupillary Changes as a Potential Biomarker for Escitalopram in Relation to CYP2C19 Polymorphism [NCT00397059]Phase 416 participants (Anticipated)Interventional2006-12-31Completed
Prevention of Post-Stroke Depression - Treatment Strategy [NCT00071643]201 participants (Actual)Interventional2002-09-30Completed
[NCT00220480]60 participants (Anticipated)Interventional2005-02-28Recruiting
Prophylactic Treatment of Peginterferon-associated Psychopathology. A Double-blind Placebo-controlled Trial on the Effects of Escitalopram (Lexapro®) in Patients Treated With Peginterferon and Ribavirin (POPS Study) [NCT00133276]Phase 2/Phase 380 participants (Anticipated)Interventional2005-08-31Completed
Placebo-Controlled Trial of Cipralex in the Treatment of Negative Symptoms in Schizophrenia [NCT00148447]Phase 340 participants Interventional2004-11-30Completed
A Double-Blind, Placebo-Controlled Investigation Into the Safety and Efficacy of Escitalopram for Depression in Multiple Sclerosis [NCT00151294]Phase 420 participants Interventional2004-11-30Terminated
A Double-Blind, Placebo-Controlled Trial of Escitalopram as a Mood Stabilizer for Bipolar II Disorder [NCT00156325]Phase 210 participants Interventional2004-02-29Completed
Evaluation of the Therapeutic Effects of Escitalopram in Pulmonary Hypertension, Either Primary or Associated [NCT00190333]Phase 330 participants (Actual)Interventional2005-06-30Completed
Depression: The Search for Treatment-Relevant Phenotypes [NCT00222820]Phase 435 participants Interventional2002-04-30Completed
Caregiver Psychiatric Symptomatology and it's Relationship to Service Utilization by Children With Asthma [NCT00223288]175 participants Observational2003-03-31Completed
A Double-Blind, Placebo-Controlled Study of Acamprosate Added to Escitalopram and Behavioral Treatment in Major Depressive Disorder (MDD) With Comorbid Alcohol Abuse/Dependence [NCT00452543]Phase 423 participants (Actual)Interventional2007-03-31Completed
Escitalopram Treatment of Night Eating Syndrome: a Randomized Controlled Trial [NCT00636649]40 participants (Actual)Interventional2008-10-31Completed
Developing New Clinical Management Strategies for Antidepressant Treatments [NCT02082392]Phase 43 participants (Actual)Interventional2012-09-30Completed
Combining Medications to Enhance Depression Outcomes [NCT00590863]Phase 4665 participants (Actual)Interventional2008-03-31Completed
fMRI and Genotype Markers of Antidepressant Side Effects and Response in Young Adults Compare to Older Adults [NCT00707863]Phase 417 participants (Actual)Interventional2008-05-31Completed
Project 1: Clinical Neurobiology of Serotonin and Addiction [NCT00732901]Phase 2/Phase 3160 participants (Actual)Interventional2008-06-30Completed
A Double-blind, Fixed-dose Study of Escitalopram in Adult Patients With Major Depressive Disorder [NCT00668525]Phase 3877 participants (Actual)Interventional2008-04-30Completed
fMRI Studies of Emotional Circuitry in Major Depression [NCT00749125]99 participants (Actual)Interventional2001-07-31Completed
Antidepressant Therapy for Functional Dyspepsia [NCT00248651]Phase 2/Phase 3292 participants (Actual)Interventional2006-10-31Completed
Feasibility Study to Prevent Post-ICU Depression [NCT00872027]Phase 415 participants (Actual)Interventional2009-04-30Completed
The Efficacy and Safety of Escitalopram Augmentation of Risperidone and Olanzapine in Treatment Resistant Schizophrenia: a Double Blind Placebo Controlled Pilot Study [NCT00231335]Phase 430 participants (Anticipated)Interventional2006-03-31Completed
Investigation of Efficacy and Response Speed of a Combination Treatment of Escitalopram and Repetitive Transcranial Magnetic Stimulation [NCT00232700]42 participants (Anticipated)Interventional2005-09-30Completed
Effect of Self-administered Transcranial Direct Stimulation in Patients With Major Depressive Disorder: A Prospective, Randomized, Single-blinded Clinical Trial [NCT04543123]Phase 458 participants (Actual)Interventional2017-11-16Completed
Evaluation of the Effects of Duloxetine on Norepinephrine Transporter Inhibition in Healthy Subjects [NCT00414323]Phase 135 participants (Actual)Interventional2006-11-30Completed
Fixed Dose Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder [NCT00239954]Phase 30 participants Interventional2005-03-31Active, not recruiting
Effects of Dialectical Behavioral Therapy and Escitalopram on Impulsive Aggression, Affective Instability and Cognitive Processing in Borderline Personality Disorder [NCT00255554]0 participants InterventionalRecruiting
Six Week Double Blind, Randomized Trial of Escitalopram Add On for Treatment Resistant Bipolar Depression [NCT00272025]Phase 11 participants (Actual)Interventional2006-10-31Terminated(stopped due to Lundbeck withdrew committment - expiring patents and prolonged inactivity)
Mineralocorticoid Receptor in the Treatment of Severe Depression: A Randomized, Double Blind, and Placebo Controlled Trial [NCT00295347]65 participants (Anticipated)Interventional2005-12-31Completed
Combined Escitalopram/Bupropion as First Line Treatment for Depression, a Replication. [NCT00296712]Phase 455 participants (Actual)Interventional2005-02-28Completed
Serotonergic Modulation of Cognition, Emotion and Brain Activation in Healthy Volunteers [NCT04239339]Phase 466 participants (Actual)Interventional2020-04-28Completed
Medication Treatment Following Neuropsychologic, Dichotic and f-MRI Tests in Depressed Outpatients With Repeat f-MRI Following Treatment [NCT00296777]Phase 428 participants (Actual)Interventional2004-12-31Completed
Memory Functioning and Antidepressant Treatment: A Randomized Controlled Trial Comparing Escitalopram and Bupropion XL [NCT00296933]Phase 360 participants (Anticipated)Interventional2005-12-31Completed
A Proof of Concept Study of the Prevention of Mild Cognitive Impairment and Eventual Alzheimer's Disease Using F18 Flutemetamol [NCT03274817]Phase 15 participants (Actual)Interventional2009-06-18Terminated(stopped due to Insufficient Enrollment)
Sequence Towards Remission in Depression [NCT01628783]Phase 490 participants (Anticipated)Interventional2012-06-30Recruiting
Integrated Biological Markers for the Prediction of Treatment Response in Depression [NCT01655706]Phase 3211 participants (Actual)Interventional2012-04-23Completed
A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of ABT-436 in Major Depressive Disorder [NCT01741142]Phase 219 participants (Actual)Interventional2012-01-31Terminated(stopped due to Decision based on strategic determination; not safety.)
Open, Two Periods, Two Treatments, Two Sequences, Cross-over, Randomized Study With Single Dosage of Two Oral Preparations in Tablets Containing Escitalopram 10 mg (Product From GlaxoSmithKline México, S.A. de C.V. vs. Lexapro® 10mg, Lundbeck México, S.A. [NCT01745601]Phase 126 participants (Actual)Interventional2010-05-04Completed
Enhanced Motor Recovery Using Serotonergic Agents in Stroke [NCT01751854]Phase 130 participants (Actual)Interventional2004-12-31Completed
Monoaminergic Modulation of Motor Function in Subacute Incomplete Spinal Cord Injury [NCT01753882]Phase 188 participants (Anticipated)Interventional2012-02-29Active, not recruiting
Algorithm Guided Treatment Strategies for Major Depressive Disorder [NCT01764867]Phase 41,080 participants (Anticipated)Interventional2012-06-30Recruiting
Serotonergic Modulation of Motor Function in Subacute and Chronic SCI [NCT01788969]Phase 142 participants (Actual)Interventional2005-06-30Active, not recruiting
Antidepressant Treatments During Pregnancy and Lactation: Prediction of Drug Exposure Through Breastfeeding and Evaluation of Drug Effect on the Neonatal Adaptation and the Development of the Young Child [NCT01796132]Phase 4500 participants (Anticipated)Interventional2012-08-31Recruiting
A Multicenter, Randomized, Double-Blind, Placebo and Escitalopram Controlled Trial of the Safety and Efficacy of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety Disorder [NCT00481325]Phase 2/Phase 3260 participants (Actual)Interventional2007-07-31Completed
A Single-arm, Open-label, Multi-center Study to Investigate Efficacy and Safety of Lexapro on Acute Treatment of Severe Depression [NCT01814085]Phase 4225 participants (Actual)Interventional2010-02-28Completed
Escitalopram in the Long-term Treatment of Major Depressive Disorder With Associated Anxiety Symptom [NCT01814098]Phase 4318 participants (Actual)Interventional2009-07-07Completed
Adjunctive Treatment of Major Depression Utilizing Auricular Acupuncture [NCT02579343]13 participants (Actual)Interventional2015-08-31Completed
Phase III Randomized, Double-Blind, Placebo-Controlled Evaluation of Citalopram for the Treatment of Hot Flashes [NCT00363909]Phase 3254 participants (Actual)Interventional2006-11-30Completed
An Objective Double-blind Evaluation of Bupropion and Citalopram in an Individual With Friedreich Ataxia [NCT01716221]Phase 41 participants (Actual)Interventional2012-10-31Completed
Antidepressant Treatment at an Inner City Asthma Clinic [NCT01324700]Phase 4139 participants (Actual)Interventional2010-07-31Completed
"Response Variability in Treatment Resistant Depression - an Ancillary Study to Sequenced Treatment Alternatives to Relieve Depression (STAR*D)" [NCT00375843]Phase 4118 participants (Actual)Interventional2005-01-31Completed
Pipamperone/Citalopram (PNB01) Versus Citalopram (CIT) and Versus Pipamperone (PIP) in the Treatment of Moderate to Severe Major Depressive Disorder (MDD): a Randomized, Double-blind Phase III Study of 10 Weeks [NCT01312922]Phase 3555 participants (Actual)Interventional2011-09-30Completed
Neurobiological Bases of Placebo Response in Major Depressive Disorder [NCT01787240]Phase 420 participants (Actual)Interventional2012-11-30Terminated(stopped due to Recruitment difficulties)
A Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment. [NCT05603104]Phase 31,254 participants (Anticipated)Interventional2023-08-01Not yet recruiting
Magnetic Resonance Imaging Study of Cognitive-Behavior Therapy for Major Depressive Disorder [NCT01460212]Phase 480 participants (Anticipated)Interventional2011-12-31Recruiting
Optimized Predictive Treatment In Medications for Unipolar Major Depression (OPTIMUM-D) [NCT05017311]Phase 4400 participants (Anticipated)Interventional2023-01-20Recruiting
Integrated Biological Markers for the Prediction of Treatment Response in Depression: Validation Study [NCT04162522]Phase 31 participants (Actual)Interventional2019-12-23Completed
Fixed Dose Comparison of Escitalopram to an Active Comparator in Severely Depressed Patients [NCT00384436]Phase 4580 participants (Anticipated)Interventional2006-10-31Completed
The DPP-4 Inhibitor Vildagliptin as Adjunct in Major Depressive Disorder Patients: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Trial [NCT04410341]Phase 1/Phase 2100 participants (Anticipated)Interventional2020-05-01Recruiting
Establishment of Cessation Therapy by Clinical Trials for Subjects With Betel-quid Dependence and Oral Pre-cancer [NCT03010761]Phase 290 participants (Actual)Interventional2016-01-14Terminated(stopped due to all participants finished the trial)
Efficacy of Interpersonal Psychotherapy in Treatment Resistant Depression [NCT01896349]74 participants (Anticipated)Interventional2013-04-30Recruiting
Treatment of Pediatric OCD for SRI Partial Responders [NCT00074815]Phase 3124 participants (Actual)Interventional2003-09-30Completed
[NCT02423694]252 participants (Anticipated)Interventional2013-09-30Recruiting
Biochemical Brain Changes Correlated With the Antidepressant Effect of Escitalopram: A Magnetic Resonance Spectroscopic Imaging Study [NCT00183677]Phase 497 participants (Actual)Interventional2003-07-31Completed
A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression [NCT02418585]Phase 3236 participants (Actual)Interventional2015-08-07Completed
Prediction of the Therapeutic Response in Depression Based on an Early Neuro-computational Modeling Assessment of Motivation [NCT05866575]136 participants (Anticipated)Interventional2023-06-01Not yet recruiting
Assessing Tolerability and Efficacy of Vortioxetine Versus SSRIs in Elderly Patients With Depression: a Pragmatic, Multicenter, Open-label, Parallel-group, Superiority, Randomized Trial [NCT03779789]Phase 4362 participants (Actual)Interventional2019-02-01Completed
A Randomised Placebo-Controlled Trial of Escitalopram and Nortriptyline With Standard Psychological Care for Depression in Parkinson's Disease [NCT03652870]Phase 352 participants (Actual)Interventional2021-03-05Completed
A Double-blinded 6-week Prospective Study to Evaluate the Remission Rate According to Dose of Escitalopram (Lexapro®) in Patients With Major Depressive Disorder: a Preliminary Study [NCT01594866]Phase 460 participants (Anticipated)Interventional2012-05-31Completed
Pharmacologic Influence of Escitalopram on the Reduction of Fear Acquisition and Triggered Renewal During Fear Conditioning: a Model for the Prevention and Persistence of Learned Fear and Anxiety in Response to Trauma and Stress [NCT01398514]Phase 465 participants (Actual)Interventional2008-10-31Completed
Efficacy and Safety of Escitalopram in the Treatment of Depressive Patients With Acute Coronary Artery Syndrome: A Double-blind Placebo-controlled Trial [NCT00419471]Phase 4300 participants (Actual)Interventional2007-05-31Completed
Antidepressant Response in Older Adults With Comorbid PTSD and MDD [NCT04697693]Phase 41 participants (Actual)Interventional2021-03-03Terminated(stopped due to Unable to recruit participants in a timely fashion due to COVID pandemic)
Ramelteon for Sleep Initiation Insomnia in Panic Disorder Who Are Also on Escitalopram for Anxiety: A Double Blind, Randomized Clinical Trial [NCT00746239]11 participants (Actual)Interventional2008-08-31Terminated(stopped due to Funding for continuation was not received.)
Phase 4 Clinical Pharmacogenomics of Antidepressant Response [NCT00384020]402 participants (Actual)Observational2006-01-31Completed
Mechanisms of Antidepressant Non-Response in Late-Life Depression [NCT01931202]138 participants (Actual)Interventional2014-02-19Completed
Antidepressant Response in the Treatment of Depressive Symptoms and Frailty Characteristics in Older Adults [NCT01973283]Phase 4100 participants (Actual)Interventional2014-02-19Completed
Pilot Randomized Feasibility Trial of Tele-Interpersonal Psychotherapy and Tele-Pharmacotherapy for Depression in Patients With Non-Metastatic Breast Cancer [NCT04973930]Phase 320 participants (Anticipated)Interventional2022-03-01Suspended(stopped due to U.S. Department of Health and Human Services OHRP issued an FWA restriction on NYSPI research that included a pause of human subjects research as of June 23, 2023. This study will resume recruitment after OHRP has approved the resumption of research.)
Effects on Aripiprazole on the Steady-State Pharmacokinetics of Escitalopram in Healthy Subjects [NCT00361790]Phase 125 participants Interventional2006-08-31Completed
Research on Standardized Electronic Cognitive Training Technique in Early Stage of Senile Depression With Cognitive Impairment [NCT05588102]128 participants (Anticipated)Interventional2021-05-18Recruiting
Clinical Study to Investigate the Effect of Administration of Selective Serotonin Reuptake Inhibitors (SSRIs) and an Opioid on Ventilation [NCT05470465]Phase 127 participants (Actual)Interventional2022-09-01Completed
Escitalopram Effects on CSF Amyloid Beta Total Concentrations [NCT02161458]Phase 498 participants (Actual)Interventional2014-06-30Completed
Clinical Study Evaluating the Efficacy of Nitazoxanide and Escitalopram as Adjuvant Therapies in Patients With Rheumatoid Arthritis [NCT05480878]Phase 390 participants (Actual)Interventional2022-12-02Completed
Pharmacotherapy Relapse Prevention in Body Dysmorphic Disorder [NCT00149799]Phase 3100 participants (Actual)Interventional2005-05-31Completed
Predictors of Antidepressant Treatment Response: The Emory CIDAR [NCT00360399]344 participants (Actual)Interventional2006-08-31Completed
Effect of Lactobacillus Plantarum 299v Supplementation on Major Depression Treatment [NCT02469545]Phase 260 participants (Actual)Interventional2014-06-30Completed
The Effects of Serotonergic Challenge on Motor Learning and Neuroplasticity [NCT03162185]Phase 460 participants (Anticipated)Interventional2017-04-01Recruiting
Effect of Serotonin and Levodopa Functional Recovery in Patients With Cerebral Infarction [NCT02386475]Phase 439 participants (Actual)Interventional2015-01-31Completed
Cognitive Dysfunction in Patients With Major Depressive Disorder, Clinical Peculiarities, Biological Markers, and Treatment Efficacy [NCT03187093]Phase 4150 participants (Anticipated)Interventional2016-10-31Recruiting
Efficacy of Hydroxyzine Versus Treatment as Usual for Panic Disorder: An Eight-Week, Open Label, Pilot, Randomized Controlled Trial. [NCT05737511]Phase 480 participants (Anticipated)Interventional2023-12-30Not yet recruiting
Pharmacovigilance in Gerontopsychiatric Patients [NCT02374567]Phase 3407 participants (Actual)Interventional2015-01-31Terminated
CBT Augmentation of SSRI Treatment for Geriatric GAD [NCT00601965]73 participants (Actual)Interventional2007-10-31Completed
Connectivity Affecting the Antidepressant REsponse (The CAARE Study) [NCT02332291]Phase 495 participants (Actual)Interventional2015-04-30Completed
Clinical Trial of Serotonin Medication Combination in Cocaine Dependence [NCT01535573]Phase 2108 participants (Actual)Interventional2010-12-31Completed
A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression [NCT02417064]Phase 3346 participants (Actual)Interventional2015-08-10Completed
Escitalopram for Agitation in Alzheimer's Disease [NCT03108846]Phase 3392 participants (Anticipated)Interventional2018-01-03Recruiting
A Phase 4, 8-week, Double-blind, Randomized Study Comparing Switching to Duloxetine or Escitalopram in Patients With Major Depressive Disorder and Residual Apathy in the Absence of Depressed Mood [NCT00985504]Phase 4483 participants (Actual)Interventional2009-09-30Completed
A Double-blind, Placebo- and Active-controlled, Fixed-dose Study of Vilazodone in Patients With Major Depressive Disorder [NCT01473381]Phase 41,162 participants (Actual)Interventional2011-12-31Completed
Factors of Treatment Response in Major Depressive Disorder [NCT00200902]Phase 488 participants (Actual)Interventional2005-08-31Completed
Assessing the Impact of Escitalopram on Sperm DNA Fragmentation: A Randomized Placebo Controlled [NCT03527043]Phase 270 participants (Anticipated)Interventional2017-10-01Recruiting
White Matter and Emotional and Cognitive Control in Late-Onset Depression [NCT01728194]Phase 4121 participants (Actual)Interventional2012-07-31Completed
Improving Quality of Life and Social Functionality With Escitalopram in the Treatment of Major Depressive Disorder With Anxiety Symptom [NCT01870843]Phase 4261 participants (Actual)Interventional2014-03-31Completed
Escitalopram in the Treatment of Outpatients With Severe Asthma and Moderate or Severe Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial [NCT00621946]Phase 426 participants (Actual)Interventional2008-03-31Completed
Time to Remission of Depressive Symptoms With Combined SSRI and Ramelteon [NCT00642694]Phase 329 participants (Actual)Interventional2007-05-31Terminated(stopped due to Enrollment discontinued based on mutually agreed upon decision by PI and funding sponsor)
QEEG Predictors of Response for Psychotherapy Compared to Pharmacotherapy in Depression [NCT00824044]Phase 439 participants (Actual)Interventional2008-07-31Completed
Effects of Combined Memantine (Namenda) Plus Escitalopram (Lexapro) Treatment in Elderly Depressed Patients With Cognitive Impairment [NCT01876823]Phase 2/Phase 360 participants (Actual)Interventional2006-04-30Completed
Effects of Treatment on Decision-making in Major Depression [NCT01916824]Phase 453 participants (Actual)Interventional2013-08-31Completed
Effectiveness and Safety of Transcutaneous Electrical Cranial-auricular Acupoint Stimulation (TECAS) for Patients With Mild-to-moderate Depression. [NCT03909217]Phase 2/Phase 3470 participants (Anticipated)Interventional2019-07-29Recruiting
A Randomized, Double-Blind, Parallel-Group, Active-Controlled, Flexible-Dose Study Evaluating the Effect of Lu AA21004 vs Escitalopram on Sexual Functioning in Adults With Well-Treated Major Depressive Disorder Experiencing Selective Serotonin Reuptake In [NCT01364649]Phase 3447 participants (Actual)Interventional2011-06-30Completed
What is the Effectiveness and Safety of Mirtazapine Versus Escitalopram in Alleviating Cancer-associated Poly-symptomatology (MIR-P)? A Mixed-method Randomized Controlled Trial Protocol [NCT04763135]Phase 31 participants (Actual)Interventional2021-12-15Terminated(stopped due to difficulties in recruiting)
Acupuncture and Escitalopram for Treating Major Depression Clinical Study (AE-TMDCS): Study Design of a Randomized Controlled Trial [NCT05901571]216 participants (Anticipated)Interventional2023-09-30Not yet recruiting
Biological Predictors of Response to Antidepressants [NCT00456014]37 participants (Actual)Interventional2006-09-30Completed
Pentoxifylline as an Adjunct to Citalopram in Adult Patients With Major Depressive Disorder: A Randomized, Double-Blind, Placebo-Controlled Trial [NCT05271084]Phase 1/Phase 2100 participants (Actual)Interventional2021-11-10Completed
Brain Imaging and Treatment Studies of the Night Eating Syndrome [NCT01401595]Phase 387 participants (Actual)Interventional2009-12-31Completed
Study on the Optimal Diagnosis and Treatment Strategy of Major Depressive Disorder Based on Anhedonia [NCT05389046]252 participants (Anticipated)Interventional2022-10-31Not yet recruiting
Comparative Efficacy of Duloxetine vs Escitalopram in Patients With Fibromyalgia [NCT03487211]Phase 2/Phase 3200 participants (Actual)Interventional2018-04-09Completed
Pharmacogenetically-guided Escitalopram Treatment for Pediatric Anxiety: Aiming to Improve Safety and Efficacy (PrEcISE) [NCT04623099]Phase 4132 participants (Anticipated)Interventional2021-03-08Recruiting
Determining Optimal Treatment Sequences in Anxious Depression (DOTS-AD) [NCT04245748]Phase 484 participants (Anticipated)Interventional2020-03-01Recruiting
Acute, Double-blind, Adaptively Randomized Treatment With Duloxetine or Escitalopram, Followed by Open-label Naturalistic Follow-up. [NCT04245436]Phase 460 participants (Anticipated)Interventional2020-01-01Recruiting
The Effect of Patient and Investigator Expectation on the Efficacy of Escitalopram in the Treatment of Patients With Major Depressive Disorder. [NCT02480400]52 participants (Actual)Interventional2010-06-30Completed
Treatment of Geriatric Depression With Mild Cognitive Impairment: A Double-blind Placebo-Controlled Trial of Namenda (Memantine) Augmentation of Lexapro (Escitalopram) in Depressed Patients at Least 60 Years of Age [NCT01902004]Phase 4115 participants (Actual)Interventional2013-10-31Completed
Proof of Concept Study to Treat Negative Affect in Chronic Low Back Pain [NCT04747314]Phase 2/Phase 3300 participants (Anticipated)Interventional2021-03-31Recruiting
Depression Treatment and Aβ Dynamics: A Study of Alzheimer's Disease Risk (ABD Study) [NCT05004987]Phase 490 participants (Anticipated)Interventional2022-02-04Recruiting
A Pilot Study Examining the Gut Microbiota in Patients With Obsessive-Compulsive Disorder vs. Healthy Controls and Following 12-weeks of Open-label Selective Serotonin Reuptake Inhibitors Treatment [NCT02285699]43 participants (Anticipated)Interventional2014-11-01Completed
Mechanism of Antidepressant-Related Dysfunctional Arousal in High-Risk Youth [NCT02553161]210 participants (Anticipated)Interventional2015-12-31Active, not recruiting
A Multicenter, Randomized, Double-blind Study to Evaluate the Efficacy, Safety and Tolerability of an Oral Aripiprazole/Escitalopram Combination Therapy in Patients With Major Depressive Disorder [NCT01111565]Phase 3137 participants (Actual)Interventional2010-10-04Terminated(stopped due to The study was terminated early due to Sponsor decision, closure of this combination therapy program is unrelated to any safety issues, no signals of concern.)
Cognitive-Behavioral Therapy and Pharmacotherapy Augmentation for Generalized Anxiety Disorder: A Pilot Investigation [NCT00219349]Phase 425 participants (Actual)Interventional2005-01-31Completed
Pilot Study to Evaluate Escitalopram in Obsessive-compulsive Disorder [NCT00215137]Phase 214 participants (Actual)Interventional2004-10-31Completed
Advancing Personalized Antidepressant Treatment Using PET/MRI [NCT02623205]Phase 485 participants (Actual)Interventional2015-05-31Completed
A Multi-centre, Randomised, Double-blind, Parallel Active-controlled Study Evaluating the Efficacy, Safety and Tolerability of Bupropion Hydrochloride Extended-release (Bupropion XL 300mg Once Daily), Escitalopram Oxalate (Escitalopram, 10mg-20mg Once Dai [NCT02191397]Phase 3534 participants (Actual)Interventional2015-02-10Completed
Brain Function and Structure in Cocaine Dependence [NCT02080832]Phase 254 participants (Actual)Interventional2010-02-28Completed
A Randomized, Double-blind, Multicenter Active-controlled Study to Evaluate the Efficacy, Pharmacokinetics, Safety and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depressio [NCT03434041]Phase 3252 participants (Actual)Interventional2018-05-25Completed
A Randomized, Multicenter, Double-Blind, Flexibly-dosed, Efficacy and Safety Study of Escitalopram in the Treatment of Children and Adolescents With Generalized Anxiety Disorder [NCT03924323]Phase 4273 participants (Actual)Interventional2019-05-30Completed
Comparison of Antidepressants in the Real-World: Retrospective Cohort Study Using Big Data [NCT04446039]405,349 participants (Actual)Observational2022-07-04Completed
Testing an Imaging Biomarker for Treatment Stratification in Major Depression [NCT02137369]Phase 477 participants (Actual)Interventional2014-09-30Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00070941 (1) [back to overview]Change in Hamilton Depression Scale
NCT00074815 (1) [back to overview]Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
NCT00086307 (1) [back to overview]Montgomery Asberg Depression Rating Scale (MADRS)
NCT00101452 (1) [back to overview]Hamilton Rating Scale for Depression (HAM-D)
NCT00105586 (2) [back to overview]Quality of Life
NCT00105586 (2) [back to overview]Response Using Clinical Global Impressions-Improvement Scale (CGI-I)
NCT00107120 (3) [back to overview]Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score
NCT00107120 (3) [back to overview]Children's Global Assessment Scale
NCT00107120 (3) [back to overview]Clinical Global Impressions - Improvement
NCT00136318 (5) [back to overview]Proportion of Patients Without Depression (Defined as a MADRS Score of 13 or Higher)
NCT00136318 (5) [back to overview]Severe Depression Defined as a MADRS Score of 25 or Higher
NCT00136318 (5) [back to overview]Sustained Virologic Response
NCT00136318 (5) [back to overview]Incidence of Major Depression Defined by Diagnostic and Statistical Manual IV (DSM-IV) Criteria
NCT00136318 (5) [back to overview]Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher
NCT00149799 (5) [back to overview]Phase I Response to Escitalopram (as Measured by the BDD-YBOCS)
NCT00149799 (5) [back to overview]Change in Quality of Life (Q-LES-Q-SF) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)
NCT00149799 (5) [back to overview]Change in Functional Impairment Symptoms (LIFE-RIFT) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)
NCT00149799 (5) [back to overview]Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)
NCT00149799 (5) [back to overview]Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS)
NCT00149825 (2) [back to overview]Remission of Depression (%)
NCT00149825 (2) [back to overview]Remission of Insomnia
NCT00166114 (1) [back to overview]Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8
NCT00166296 (4) [back to overview]Total Score in the Montgomery-Asberg Depression Rating Scale
NCT00166296 (4) [back to overview]Total Score in the Depression Subscale of the Hospital Anxiety and Depression Scale.
NCT00166296 (4) [back to overview]Number of Participants With Sustained Hepatitis C Viral Response (Negativization of Serum Hepatitis C Virus Ribonucleic Acid).
NCT00166296 (4) [back to overview]Number of Participants Who Developed a Major Depressive Episode According to Diagnostic & Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Criteria During the First 12 Weeks of Antiviral Treatment.
NCT00177216 (3) [back to overview]Change in PSG Sleep Efficiency for the Second Night in the Sleep Lab at Each Timepoint
NCT00177216 (3) [back to overview]Change in Pittsburgh Sleep Quality Index
NCT00177216 (3) [back to overview]Change in Diary Sleep Efficiency
NCT00177294 (1) [back to overview]Remission
NCT00177671 (4) [back to overview]Number of Participants With Recurrence of Major Depression
NCT00177671 (4) [back to overview]Percentage of Participants With Mild Cognitive Impairment Converting to Dementia.
NCT00177671 (4) [back to overview]Cognitive Instrumental Activities of Daily Living (IADL)
NCT00177671 (4) [back to overview]Global Cognitive Performance
NCT00183677 (1) [back to overview]Responder and Remission Status (%), Based on the Depression Rating Scale Score
NCT00200902 (3) [back to overview]Average Change in 3 Weeks of Participant Treatment Expectations
NCT00200902 (3) [back to overview]Change in Hamilton Depression Assessment Score
NCT00200902 (3) [back to overview]Response as Assessed by Participants' Change in Depression Rating
NCT00209170 (1) [back to overview]Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week 24
NCT00215137 (1) [back to overview]Yale Brown Obsessive Compulsive Scale
NCT00219349 (8) [back to overview]Change in Clinical Global Impressions-Severity Index
NCT00219349 (8) [back to overview]Change in Beck Depression Inventory-II
NCT00219349 (8) [back to overview]Change in Hamilton Anxiety Rating Scale Score
NCT00219349 (8) [back to overview]Change in Hamilton Rating Scale for Depression
NCT00219349 (8) [back to overview]Change in Penn State Worry Questionnaire
NCT00219349 (8) [back to overview]Change in State-Trait Anxiety Inventory, State Subscale
NCT00219349 (8) [back to overview]Clinical Global Impressions-Improvement Index
NCT00219349 (8) [back to overview]Change in Generalized Anxiety Disorder Severity Scale
NCT00220701 (6) [back to overview]Beck Depression Inventory (BDI)
NCT00220701 (6) [back to overview]Beck Depression Inventory (BDI)
NCT00220701 (6) [back to overview]Hamilton-Depression Rating Scale (HDRS-24 Items)
NCT00220701 (6) [back to overview]Hamilton-Depression Rating Scale (HDRS-24 Items)
NCT00220701 (6) [back to overview]Clinical Global Impressions - Severity (CGI-S)
NCT00220701 (6) [back to overview]Clinical Global Impressions - Severity (CGI-S)
NCT00248651 (4) [back to overview]Dyspepsia-Specific Quality of Life
NCT00248651 (4) [back to overview]Maximum Tolerated Volume by Nutrient Drink Test
NCT00248651 (4) [back to overview]Gastric Emptying Half-Time (T1/2)
NCT00248651 (4) [back to overview]Self-Report of Adequate Relief of Dyspepsia (Yes/No) For at Least 50% of Weeks 3 -12 of Treatment
NCT00352885 (5) [back to overview]Number of IL-2 Treatments Tolerated
NCT00352885 (5) [back to overview]Hamilton Depression Rating Scale (HAM-D) Score
NCT00352885 (5) [back to overview]Plasma Concentrations of Adrenocorticotropic Hormone (ACTH)
NCT00352885 (5) [back to overview]Plasma Concentrations of Interleukin 6 (IL-6)
NCT00352885 (5) [back to overview]Plasma Concentrations of Cortisol
NCT00360399 (6) [back to overview]Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, in Intent to Treat Sample
NCT00360399 (6) [back to overview]Remission From Major Depressive Episode Among Participants Who Completed the Intervention
NCT00360399 (6) [back to overview]Number of Participants Achieving Remission From Major Depressive Episode After 12 Weeks of Combined Treatment, for Those Patients Who do Not Achieve Remission With Monotherapy
NCT00360399 (6) [back to overview]Remission From Major Depressive Episode in Intent to Treat Sample
NCT00360399 (6) [back to overview]Number of Participants Experiencing Depression Recurrence Following Remission to Monotherapy Treatment
NCT00360399 (6) [back to overview]Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, Among Participants Who Completed the Intervention
NCT00361218 (1) [back to overview]Serum Brain-derived Neurotrophic Factor (BDNF) Levels
NCT00367341 (2) [back to overview]Remission Defined as Hamilton Depression Rating Scale-17 Score of Less Than or Equal to 7 at 12 Weeks
NCT00367341 (2) [back to overview]Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks
NCT00387348 (3) [back to overview]Side Effect Burden
NCT00387348 (3) [back to overview]Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder
NCT00387348 (3) [back to overview]Change in Hamilton Depression Rating Scale (HAM-D) Scores
NCT00404755 (2) [back to overview]Hamilton Depression Scale (HAM-D)
NCT00404755 (2) [back to overview]Clinical Global Impression Scale (CGI)
NCT00406640 (13) [back to overview]Clinical Global Impression Improvement (CGI-I) Score at 8 Weeks
NCT00406640 (13) [back to overview]Percentage of Responders Achieving Remission at Final On-therapy Evaluation (Double Blind Continuation Phase)
NCT00406640 (13) [back to overview]Percentage of Responders Improving Response to Remission During 6-month Double Blind Continuation Phase
NCT00406640 (13) [back to overview]Percentage of Responders Maintaining Response to Treatment at Final On-therapy Evaluation (Double Blind Continuation Phase)
NCT00406640 (13) [back to overview]Percentage of Patients Achieving Response to Treatment at Final On-therapy Evaluation (Acute Phase)
NCT00406640 (13) [back to overview]Change in Hamilton Psychiatric Rating Scale for Anxiety From Baseline to Week 8 (HAM-A) Score
NCT00406640 (13) [back to overview]Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8
NCT00406640 (13) [back to overview]Percentage of Non-Responders Achieving Response at Final Evaluation of 6-month Open-Label (OL)Extension Phase
NCT00406640 (13) [back to overview]Percentage of Non-Responders Achieving Remission at Final Evaluation of 6-month Open-Label Extension Phase
NCT00406640 (13) [back to overview]Percentage of Patients Achieving Remission at Final On-therapy Evaluation (Acute Phase)
NCT00406640 (13) [back to overview]Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8
NCT00406640 (13) [back to overview]Discontinuation-Emergent Signs and Symptoms (DESS) Total Score
NCT00406640 (13) [back to overview]Change in Clinical Global Impression Severity (CGI-S) Score From Baseline to Week
NCT00420004 (19) [back to overview]Clinical Global Impression of Improvement Score at Week 8
NCT00420004 (19) [back to overview]Change From Baseline to Week 8 in the 21-item Hamilton Depression Rating Scale (HAM-21) Total Score
NCT00420004 (19) [back to overview]Response and Remission Rates
NCT00420004 (19) [back to overview]Pharmacokinetics: Predicted Maximal Concentration of LY2216684 at Steady State (Cmax,ss) at Week 8 Endpoint
NCT00420004 (19) [back to overview]Change From Baseline on the 36-item Short-Form (SF-36) Health Status Survey Mental and Physical Components up to Week 8 Endpoint
NCT00420004 (19) [back to overview]Cognitive Assessment Battery: Change From Baseline in Word List Learning and Delayed Recall Test (WLDRT) up to Week 8 Endpoint
NCT00420004 (19) [back to overview]Number of Participants With at Least 1 Serious Adverse Event (Safety and Tolerability)
NCT00420004 (19) [back to overview]Change From Baseline to Week 8 in the 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score
NCT00420004 (19) [back to overview]Change From Baseline in Quick Inventory of Depressive Symptomatology Total Score up to Week 8 Endpoint
NCT00420004 (19) [back to overview]Change From Baseline in Insomnia Severity Index up to Week 8 Endpoint
NCT00420004 (19) [back to overview]Cognitive Assessment Battery: Change From Baseline in Symbol Digit Substitution Test (SDST) up to Week 8 Endpoint
NCT00420004 (19) [back to overview]Cognitive Assessment Battery: Change From Baseline in Trail Making A up to Week 8 Endpoint
NCT00420004 (19) [back to overview]Cognitive Assessment Battery: Change From Baseline in Two Digit Cancellation Test up to Week 8 Endpoint
NCT00420004 (19) [back to overview]Change From Baseline in Arizona Sexual Experiences Scale up to Week 8 Endpoint
NCT00420004 (19) [back to overview]Change From Baseline in Modified Overt Aggression (OAS-M) Scale up to Week 8 Endpoint
NCT00420004 (19) [back to overview]Change From Baseline in Hamilton Anxiety Rating Scale (HAMA) Total Score up to Week 8 Endpoint
NCT00420004 (19) [back to overview]Change From Baseline to Week 8 in Fatigue Severity Scale
NCT00420004 (19) [back to overview]Change From Baseline to Week 8 in Maier-Philipp Subscale of the 17-item Hamilton Depression Rating Scale (HAMD-17)
NCT00420004 (19) [back to overview]Change From Baseline in Beck Scale for Suicide Ideation up to Week 8 Endpoint
NCT00452543 (4) [back to overview]Total Drinks Consumed Per Week on the TLFB
NCT00452543 (4) [back to overview]Total Drinking Days on the Alcohol Timeline Followback (TLFB)
NCT00452543 (4) [back to overview]Change in Mean Score on the Hamilton Rating Scale for Depression -- 17 Items (HAM-D-17)
NCT00452543 (4) [back to overview]Total Drinks Consumed Per Drinking Day on the TLFB
NCT00456014 (3) [back to overview]Remission of Depressive Symptoms
NCT00456014 (3) [back to overview]Improvement in Scores on the Hamilton Depression Rating Scale - SSRI Phase
NCT00456014 (3) [back to overview]Remission of Depressive Symptoms - Tricyclic Phase
NCT00464711 (1) [back to overview]Response and Remitter Status at Endpoint, Based on Change in Depression Severity Rating Scores
NCT00475878 (2) [back to overview]Percentage of Participants Who Dropped Out of Buprenorphine Treatment
NCT00475878 (2) [back to overview]Depressive Symptoms
NCT00519428 (5) [back to overview]Time to Remission, Defined by the Week of Onset of Persistent Hamilton Rating Scale for Depression (HAM-D 17) <= 7, With no Subsequent HAM-D 17 > 7
NCT00519428 (5) [back to overview]Severity of Depressive Symptoms as Measured by Hamilton Rating Scale for Depression (HAM-D 17)
NCT00519428 (5) [back to overview]Remission: Persistent Hamilton Rating Scale for Depression, 17 Items (HAM-D 17) <= 7, With no HAM-D 17 >7 Through Week 12
NCT00519428 (5) [back to overview]Quality of Life, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form (SF)
NCT00519428 (5) [back to overview]Functioning, as Measured by the Social Adjustment Scale (SAS) Summary Score
NCT00523705 (1) [back to overview]Subject Daily Symptom Rating Score.
NCT00536172 (1) [back to overview]Depression as Assessed by the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16)
NCT00574847 (14) [back to overview]Spielberger State-Trait Anxiety Inventory Scales (STAI)
NCT00574847 (14) [back to overview]5HTT, Serotonin Transporter Protein
NCT00574847 (14) [back to overview]Beck Depression Inventory
NCT00574847 (14) [back to overview]Cook-Medley Hostility (Ho) Hostile Affect Sub-scale
NCT00574847 (14) [back to overview]Cook-Medley Hostility (Ho) Scale
NCT00574847 (14) [back to overview]Exercise Stressed-induced Myocardial Ischemia (ESIMI)
NCT00574847 (14) [back to overview]Mental Stress Induced Change in Heart Rate
NCT00574847 (14) [back to overview]Mental Stress Induced Change of Diastolic Blood Pressure
NCT00574847 (14) [back to overview]Mental Stress Induced Change of Systolic Blood Pressure
NCT00574847 (14) [back to overview]Perceived Stress Scale
NCT00574847 (14) [back to overview]Percentage of Participants With Adverse Events
NCT00574847 (14) [back to overview]Percentage of Participants With an Absence of Mental Stress-induced Myocardial Ischemia (MSIMI) During the 3 Mental Stressors
NCT00574847 (14) [back to overview]Percentage of Participants With Overall Mental Stress-induced Myocardial Ischemia (MSIMI)
NCT00574847 (14) [back to overview]Platelet Serotonin Binding Affinity Kd_100
NCT00590863 (2) [back to overview]Quality of Life Inventory
NCT00590863 (2) [back to overview]Quick Inventory of Depressive Symptoms
NCT00601965 (2) [back to overview]Hamilton Anxiety Rating Scale
NCT00601965 (2) [back to overview]Penn State Worry Questionnaire
NCT00621946 (6) [back to overview]IDS-SR (Inventory of Depressive Symptomatology - Self-Report)
NCT00621946 (6) [back to overview]IDS-SR (Inventory of Depressive Symptomatology - Self-Report)
NCT00621946 (6) [back to overview]ACQ (Asthma Control Questionnaire)
NCT00621946 (6) [back to overview]ACQ (Asthma Control Questionnaire)
NCT00621946 (6) [back to overview]HAM-D (Hamilton Rating Scale for Depression)
NCT00621946 (6) [back to overview]HAM-D (Hamilton Rating Scale for Depression)
NCT00636649 (12) [back to overview]Change in Weight
NCT00636649 (12) [back to overview]Night Eating Questionnaire
NCT00636649 (12) [back to overview]Number of Participants Who Had a 50% Reduction in NEQ Scores
NCT00636649 (12) [back to overview]Number of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 2
NCT00636649 (12) [back to overview]Change in Coping Inventory for Stressful Situations (CISS)
NCT00636649 (12) [back to overview]Change in Lipid Panel
NCT00636649 (12) [back to overview]Change in Three Factor Eating Questionnaire (TFEQ)
NCT00636649 (12) [back to overview]Change in Beck Anxiety Inventory (BAI) Score
NCT00636649 (12) [back to overview]Change in Beck Depression Inventory II (BDI-II) Score
NCT00636649 (12) [back to overview]Change in Glucose
NCT00636649 (12) [back to overview]Change in Perceived Stress Scale (PSS)
NCT00636649 (12) [back to overview]Number of Participants Who no Longer Meet the NESHI Criteria
NCT00642694 (9) [back to overview]Social Adjustment Scale - Self-Report (SAS-SR)
NCT00642694 (9) [back to overview]Hamilton Rating Scale for Depression 17-item
NCT00642694 (9) [back to overview]Work and Social Adjustment Scale (WSAS)
NCT00642694 (9) [back to overview]Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
NCT00642694 (9) [back to overview]Short-Form Health Survey - Version 2 (SF-36)
NCT00642694 (9) [back to overview]Sleep Latency
NCT00642694 (9) [back to overview]Patient Perception of Benefits of Care (PPBC)
NCT00642694 (9) [back to overview]Percentage of Remitters on IDS-C30 at Week 12
NCT00642694 (9) [back to overview]Work Productivity and Activity Impairment Questionnaire (WPAI)
NCT00643162 (3) [back to overview]Change in Hamilton Depression Scale (HAM-D) Score
NCT00643162 (3) [back to overview]Change in Hamilton Anxiety Scale (HAM-A) Score
NCT00643162 (3) [back to overview]Change in Beck Depression Inventory Score
NCT00668525 (2) [back to overview]Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8
NCT00668525 (2) [back to overview]Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.
NCT00702780 (2) [back to overview]% Change of Whole Brain Volume
NCT00702780 (2) [back to overview]% Change of Hippocampus Volume
NCT00707863 (1) [back to overview]17-item Hamilton Depression Rating Scale (HAM-D)
NCT00732901 (2) [back to overview]Cocaine Positive Urines
NCT00732901 (2) [back to overview]Attentional Bias as Measured by the Cocaine Stroop Task.
NCT00749125 (1) [back to overview]Activations in Different Cortical Regions Caused by Emotionally Evocative Task
NCT00754936 (2) [back to overview]Montgomery Asberg Depression Rating Scale (Depression Severity)
NCT00754936 (2) [back to overview]Hamilton Depression Rating Scale (Depression Severity)
NCT00797966 (14) [back to overview]Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 16 Score (Overall Life Satisfaction).
NCT00797966 (14) [back to overview]Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score.
NCT00797966 (14) [back to overview]Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit).
NCT00797966 (14) [back to overview]Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit).
NCT00797966 (14) [back to overview]Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit).
NCT00797966 (14) [back to overview]Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B.
NCT00797966 (14) [back to overview]Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.
NCT00797966 (14) [back to overview]Change From End of Phase A (Week 8 Visit) in Mean CGI-S Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.
NCT00797966 (14) [back to overview]Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.
NCT00797966 (14) [back to overview]Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.
NCT00797966 (14) [back to overview]Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Depression Rating Scale (HAM-D17) Score.
NCT00797966 (14) [back to overview]Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 15 Score (Satisfaction With Medication).
NCT00797966 (14) [back to overview]Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (QLES-Q-SF) Subscale Score - the Overall General Subscore (Sum of First 14 Items).
NCT00797966 (14) [back to overview]Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Score (the Mean of 3 Individual Item Scores).
NCT00807248 (9) [back to overview]Hospital Anxiety and Depression Scale (HADS)
NCT00807248 (9) [back to overview]Clinical Global Impression - Severity of Illness (CGI-S)
NCT00807248 (9) [back to overview]Clinical Global Impression - Global Improvement (CGI-I)
NCT00807248 (9) [back to overview]SDS: Work Subscale
NCT00807248 (9) [back to overview]SDS: Social Subscale
NCT00807248 (9) [back to overview]Montgomery and Åsberg Depression Rating Scale (MADRS)
NCT00807248 (9) [back to overview]Sheehan Disability Scale (SDS): Family Subscale
NCT00807248 (9) [back to overview]MADRS
NCT00807248 (9) [back to overview]Insomnia Severity Index (ISI)
NCT00810069 (18) [back to overview]Time to Confirmed Remission by a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 That is Maintained for Two Consecutive Visits
NCT00810069 (18) [back to overview]Estimated Probability of Not Reaching Confirmed Response at 12 Weeks Based on the Survival Function for the Time to Confirmed Response
NCT00810069 (18) [back to overview]Estimated Probability of Not Reaching Confirmed Remission at 12 Weeks Based on the Survival Function for the Time to Confirmed Remission
NCT00810069 (18) [back to overview]Time to Confirmed Remission as Defined by a 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Score of ≤ 5 That is Maintained for Two Consecutive Visits.
NCT00810069 (18) [back to overview]Visual Analog Scale (VAS) - Overall Pain Severity
NCT00810069 (18) [back to overview]Time to Confirmed Response by ≥ 50% Change From Baseline Reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17)
NCT00810069 (18) [back to overview]Sheehan Disability Scale (SDS) Normal Functioning Total Score
NCT00810069 (18) [back to overview]Resource Utilisation - Number of Work Hours Missed in the Last 4 Weeks
NCT00810069 (18) [back to overview]Resource Utilisation - Number of Work Hours Missed Due to Depression in the Last 4 Weeks
NCT00810069 (18) [back to overview]Resource Utilisation - Number of Visits to Primary Healthcare Provider Due to Depression in the Last 4 Weeks
NCT00810069 (18) [back to overview]Resource Utilisation - Number of Visits to Other Specialists Due to Depression in the Last 4 Weeks
NCT00810069 (18) [back to overview]Resource Utilisation - Number of Hours Worked Per Week
NCT00810069 (18) [back to overview]Resource Utilisation - Has the Participant Been Hospitalized Due to Depression in the Last 4 Weeks - Number of Participants With a Yes Response
NCT00810069 (18) [back to overview]Number of Participants With Adverse Events (AEs)
NCT00810069 (18) [back to overview]Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - United Kingdom (UK) Population Based Index Score
NCT00810069 (18) [back to overview]Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - Health State Score
NCT00810069 (18) [back to overview]Clinical Global Impressions of Severity (CGI-S) Scale
NCT00810069 (18) [back to overview]Time to Confirmed Response as Defined by ≥ 50% Reduction From Baseline Reduction in the 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) That is Reported for Two Consecutive Visits
NCT00824044 (10) [back to overview]Change in Relative Theta Power From Channel 4
NCT00824044 (10) [back to overview]Change in Relative Theta Power Channel 3
NCT00824044 (10) [back to overview]Change in Relative Beta Power From Channel 4
NCT00824044 (10) [back to overview]Change in Absolute Theta Power From Channel 1
NCT00824044 (10) [back to overview]Hamilton Depression Rating Scale (HAM-D-17) Scores
NCT00824044 (10) [back to overview]Change in Absolute Beta Power From the Ear Channel
NCT00824044 (10) [back to overview]Change in Absolute Beta Power in Channel 4
NCT00824044 (10) [back to overview]Change in Relative Theta Power From Ear Channel
NCT00824044 (10) [back to overview]Change in Relative Theta Power From Temporal Channel
NCT00824044 (10) [back to overview]Percent Change in Relative Theta Power From Week 1 of the Ear Channel
NCT00825825 (7) [back to overview]Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Happy and Fearful Faces Are Presented in a Rapid Covert Stimulus Presentation.
NCT00825825 (7) [back to overview]Number of Voxels Showing Greater Activation Following Placebo Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.
NCT00825825 (7) [back to overview]Number of Voxels Showing Greater Activation Following Escitalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.
NCT00825825 (7) [back to overview]Number of Voxels Showing Greater Activation Following Citalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.
NCT00825825 (7) [back to overview]Number of Voxels Showing Greater Activation Following Citalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.
NCT00825825 (7) [back to overview]Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.
NCT00825825 (7) [back to overview]Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Faces and a Fixation Stimulus Are Presented in an Overt Presentation.
NCT00833469 (3) [back to overview]Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)
NCT00833469 (3) [back to overview]Change in Edinburgh Postnatal Depression Scale (EPDS)
NCT00833469 (3) [back to overview]Change in Beck Anxiety Inventory (BAI)
NCT00872027 (1) [back to overview]Recruitment Feasibility, Defined as the Number of Participants Recruited and Administered a Medication Dose Within 48 Hours of Mechanical Ventilation
NCT00887679 (6) [back to overview]Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS)
NCT00887679 (6) [back to overview]Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE)
NCT00887679 (6) [back to overview]Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I)
NCT00887679 (6) [back to overview]Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory
NCT00887679 (6) [back to overview]Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)
NCT00887679 (6) [back to overview]Change From Randomization to End of Treatment for Trail Making Tet (TMT)
NCT00894543 (9) [back to overview]Change in Daily Severity of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries
NCT00894543 (9) [back to overview]Change in Daily Frequency of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries
NCT00894543 (9) [back to overview]Daily Hot Flash Bother, Recorded on Daily Diaries
NCT00894543 (9) [back to overview]Secondary Outcome: Change in Daily Hot Flash Bother Between Baseline and Week 8 as Recorded on Daily Diaries
NCT00894543 (9) [back to overview]Change in Daily Severity of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries
NCT00894543 (9) [back to overview]Daily Frequency of Hot Flashes Per Day Assessed by Prospective Daily Diaries
NCT00894543 (9) [back to overview]Daily Severity of Hot Flashes Assessed by Prospective Daily Diaries
NCT00894543 (9) [back to overview]Change in Daily Hot Flash Bother Between Baseline and Week 4 as Recorded on Daily Diaries
NCT00894543 (9) [back to overview]Change in Daily Frequency of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries
NCT00902226 (7) [back to overview]Percentage of Patients Who Achieved Remission After 12 Weeks of Treatment Using CGI-S <= 2
NCT00902226 (7) [back to overview]Percentage of Patients Who Responded to Escitalopram After 12 Weeks of Treatment Using CGI-I <= 2
NCT00902226 (7) [back to overview]Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Social
NCT00902226 (7) [back to overview]Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Family
NCT00902226 (7) [back to overview]Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Work
NCT00902226 (7) [back to overview]Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I)
NCT00902226 (7) [back to overview]Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-S)
NCT00902564 (9) [back to overview]Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)
NCT00902564 (9) [back to overview]Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Family
NCT00902564 (9) [back to overview]Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Work
NCT00902564 (9) [back to overview]Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-I)
NCT00902564 (9) [back to overview]Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-S)
NCT00902564 (9) [back to overview]Percentage of Patients Who Achieved Remission After 8 Weeks of Treatment Using CGI-S <= 2
NCT00902564 (9) [back to overview]Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score
NCT00902564 (9) [back to overview]Percentage of Patients Who Responded to Escitalopram After 8 Weeks of Treatment Using CGI-I <= 2
NCT00902564 (9) [back to overview]Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Social
NCT00918684 (3) [back to overview]WHODAS-II Disability Scale
NCT00918684 (3) [back to overview]Stroop Color-Word Test
NCT00918684 (3) [back to overview]Hamilton Depression Rating Scale.
NCT00930293 (2) [back to overview]Number of Participants Meeting Depression Remission Criteria
NCT00930293 (2) [back to overview]Weeks to Depression Remission
NCT00953745 (2) [back to overview]Fluorodopa Uptake Values in Brain Images of Aripiprazole Augmentation Responders
NCT00953745 (2) [back to overview]Depression Symptom Change on The Montgomery-Åsberg Depression Rating (MADRS) Scale Between ARP Responders and Non-responders.
NCT00955474 (15) [back to overview]Fasting Blood Glucose
NCT00955474 (15) [back to overview]Depression
NCT00955474 (15) [back to overview]CPFQ (Cognitive and Psychological Functioning Questionnaire)
NCT00955474 (15) [back to overview]Blood Level of Triglycerides at Baseline and Week 8.
NCT00955474 (15) [back to overview]Blood Level of Total Cholesterol Levels Were Collected at Baseline and Week 8.
NCT00955474 (15) [back to overview]Blood Hemoglobin A1C at Baseline and Week 8.
NCT00955474 (15) [back to overview]LDL Blood Levels at Baseline and Week 8.
NCT00955474 (15) [back to overview]RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Visuospatial/Constructional Sub-scale.
NCT00955474 (15) [back to overview]RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Total Score
NCT00955474 (15) [back to overview]RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Language Sub-scale Score.
NCT00955474 (15) [back to overview]RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Immediate Memory Sub-scale Score
NCT00955474 (15) [back to overview]HDL Blood Levels at Baseline and Week 8.
NCT00955474 (15) [back to overview]RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Delayed Memory Subscale Scores at Baseline and Week 8.
NCT00955474 (15) [back to overview]RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Attention Sub-scale Scores at Baseline and Week 8.
NCT00955474 (15) [back to overview]Psychosis
NCT00965497 (2) [back to overview]McGill Quality of Life Scale (MQOL)
NCT00965497 (2) [back to overview]Hamilton Depression Scale (HAM-D 17).
NCT00985504 (11) [back to overview]Change From Baseline in the Apathy Evaluation Scale - Clinician Rated Version (AES-C) Total Score at Week 8
NCT00985504 (11) [back to overview]Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Rating Scale at Week 8
NCT00985504 (11) [back to overview]Number of Days From Baseline to Relapse as Defined by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score ≥16 During 8 Weeks
NCT00985504 (11) [back to overview]Patient's Global Impressions of Improvement Scale (PGI-I) Rating Scale Score at Week 8
NCT00985504 (11) [back to overview]Percentage of Participants Who Discontinue Due to Lack of Efficacy During 8 Weeks
NCT00985504 (11) [back to overview]Percentage of Participants Who Relapsed During 8 Weeks
NCT00985504 (11) [back to overview]Change From Baseline in the Apathy Evaluation Scale-Clinician Rated Version (AES-C) Subscale Scores at Week 8
NCT00985504 (11) [back to overview]Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total and Item Scores at Week 8
NCT00985504 (11) [back to overview]Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Item 8 (Inability to Feel) at Week 8
NCT00985504 (11) [back to overview]Change From Baseline in the Rothschild Scale for Antidepressant Tachyphylaxis (RSAT) Total and Individual Item Scores at Week 8
NCT00985504 (11) [back to overview]Change From Baseline in the Sheehan Disability Scale (SDS) Total and Individual Scores at Week 8
NCT01020799 (6) [back to overview]Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4.
NCT01020799 (6) [back to overview]Clinical Global Impression - Severity (CGI-S) Score Change From Baseline
NCT01020799 (6) [back to overview]Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline
NCT01020799 (6) [back to overview]Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4.
NCT01020799 (6) [back to overview]Montgomery-Åsberg Depression Rating Scale (MADRS) Remission
NCT01020799 (6) [back to overview]Montgomery-Åsberg Depression Rating Scale (MADRS) Response
NCT01111539 (3) [back to overview]Phase C: Mean Clinical Global Impression - Improvement (CGI-I) Scale Score at the End of Phase C (Week 14)
NCT01111539 (3) [back to overview]Phase C: Mean Change From End of Phase B (Week 8) in the Sheehan Disability Scale (SDS) Mean Score to End of Phase C (Week 14)
NCT01111539 (3) [back to overview]Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14)
NCT01111552 (3) [back to overview]Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14)
NCT01111552 (3) [back to overview]Phase C: Mean Change From End of Phase B (Week 8) in the Sheehan Disability Scale (SDS) Mean Score to End of Phase C (Week 14)
NCT01111552 (3) [back to overview]Phase C: Clinical Global Impression - Improvement Scale (CGI-I) Score at The End of Phase C (Week 14)
NCT01111565 (3) [back to overview]Phase C: Clinical Global Impression - Improvement Scale (CGI-I) Score at the End of Phase C
NCT01111565 (3) [back to overview]Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14)
NCT01111565 (3) [back to overview]Phase C: Mean Change From End of Phase B (Week 8) in the Sheehan Disability Scale (SDS) Mean Score to End of Phase C (Week 14)
NCT01123707 (29) [back to overview]Number of Participants With Potentially Clinically Significant Physical Examination Findings
NCT01123707 (29) [back to overview]Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs), Severe (Grade 3 or Higher) TEAEs, and Discontinuations From the Trial Due to TEAEs
NCT01123707 (29) [back to overview]Percentage of Participants With Suicidal Ideation in Each Item as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)
NCT01123707 (29) [back to overview]Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities
NCT01123707 (29) [back to overview]Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities
NCT01123707 (29) [back to overview]Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Total Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Overall General Subscore
NCT01123707 (29) [back to overview]Mean Change From Baseline in Patient Global Impression - Severity of Depression Scale (PGI-S) Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Patient Global Impression - Severity of Depression Scale (PGI-S) Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) Total Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Laboratory Test Results: Prolactin
NCT01123707 (29) [back to overview]Mean Change From Baseline in Laboratory Test Results: Prolactin
NCT01123707 (29) [back to overview]Mean Change From Baseline in Laboratory Test Results: Hemoglobin A1c (HbA1c)
NCT01123707 (29) [back to overview]Mean Change From Baseline in Laboratory Test Results: Hemoglobin A1c (HbA1c)
NCT01123707 (29) [back to overview]Mean Change From Baseline in Each Item as Measured by Massachusetts General Hospital Sexual Functioning Inventory (MGH SFI) Subscale Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Body Weight
NCT01123707 (29) [back to overview]Mean Change From Baseline in Body Weight
NCT01123707 (29) [back to overview]Mean Change From Baseline in Body Weight
NCT01123707 (29) [back to overview]Mean Change From Baseline in Body Mass Index (BMI)
NCT01123707 (29) [back to overview]Mean Change From Baseline in Body Mass Index (BMI)
NCT01123707 (29) [back to overview]Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment of Akathisia (Item 4) Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment of Akathisia (Item 4) Score
NCT01123707 (29) [back to overview]Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score
NCT01123707 (29) [back to overview]Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities
NCT01198795 (1) [back to overview]Patients With Any Treatment Emergent Adverse Events (TEAEs)
NCT01214044 (4) [back to overview]Change in Dim Light Melatonin Onset
NCT01214044 (4) [back to overview]Change in Phase Angle Difference (PAD)
NCT01214044 (4) [back to overview]Change in Beck Depression Inventory II (BDI-II) Scores
NCT01214044 (4) [back to overview]Change in Hamilton Depression Rating Scale (HAM-D) Scores
NCT01244724 (1) [back to overview]Hamilton Depression Scale
NCT01271244 (2) [back to overview]High Frequency Heart Rate Variability
NCT01271244 (2) [back to overview]QT Interval Variability
NCT01312922 (1) [back to overview]Early and Sustained (Antidepressant) Response (ESR) Rate
NCT01324700 (2) [back to overview]Hamilton Rating Scale for Depression (HRSD)
NCT01324700 (2) [back to overview]Asthma Control Questionnaire (ACQ)
NCT01360866 (5) [back to overview]Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score
NCT01360866 (5) [back to overview]Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score
NCT01360866 (5) [back to overview]Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score
NCT01360866 (5) [back to overview]Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score
NCT01360866 (5) [back to overview]Adverse Events (AEs) - All Participants
NCT01364649 (3) [back to overview]Change From Baseline in the Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) Total Score at Week 8
NCT01364649 (3) [back to overview]Change From Baseline in the CSFQ-14 Total Score at All Other Time Points Assessed
NCT01364649 (3) [back to overview]Number of Participants With Shifts in the CSFQ-14 From Abnormal to Normal at Each Week Assessed
NCT01368432 (14) [back to overview]Mini Mental Status Exam (MMSE)
NCT01368432 (14) [back to overview]Mini Mental Status Exam (MMSE)
NCT01368432 (14) [back to overview]Montgomery-Asberg Depression Rating Scale (MADRS)
NCT01368432 (14) [back to overview]Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline
NCT01368432 (14) [back to overview]Quality of Life (QWL)
NCT01368432 (14) [back to overview]Quality of Life (QWL)
NCT01368432 (14) [back to overview]Satisfaction With Life (SWL)
NCT01368432 (14) [back to overview]Clinical Anxiety Scale (CAS)
NCT01368432 (14) [back to overview]Clinical Global Impression (CGI) - Severity at Baseline
NCT01368432 (14) [back to overview]Clinical Anxiety Scale (CAS)
NCT01368432 (14) [back to overview]Clinical Global Impression (CGI)- Improvement
NCT01368432 (14) [back to overview]Satisfaction With Life (SWL)
NCT01368432 (14) [back to overview]Disability Rating Scale (DRS)
NCT01368432 (14) [back to overview]Disability Rating Scale (DRS)
NCT01398514 (2) [back to overview]Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Early Extinction Trials 1 to 4
NCT01398514 (2) [back to overview]Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Acquisition Trials 1 to 5
NCT01401595 (3) [back to overview]Nocturnal Ingestions
NCT01401595 (3) [back to overview]Night Eating Symptoms
NCT01401595 (3) [back to overview]Change in Symptoms of NES
NCT01473381 (3) [back to overview]Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10
NCT01473381 (3) [back to overview]Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response
NCT01473381 (3) [back to overview]Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score
NCT01535573 (4) [back to overview]Number of Participants With Cocaine-negative Urines Collected During Treatment Period
NCT01535573 (4) [back to overview]Proportion of Cocaine-positive Urines Per Week
NCT01535573 (4) [back to overview]Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test
NCT01535573 (4) [back to overview]Retention as Assessed by Number of Participants Remaining in Treatment
NCT01716221 (4) [back to overview]International Cooperative Ataxia Rating Scale (ICARS)
NCT01716221 (4) [back to overview]Hamilton Depression Rating Scale
NCT01716221 (4) [back to overview]Comparison of FARS and ICARS
NCT01716221 (4) [back to overview]Friedreich Ataxia Rating Scale (FARS)
NCT01728194 (2) [back to overview]Change in Depression Severity (Measured by Hamilton Depression Rating Scale)
NCT01728194 (2) [back to overview]Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale)
NCT01787240 (3) [back to overview]Effects of Acute Tryptophan Depletion on Mood
NCT01787240 (3) [back to overview]Effects of Acute Tryptophan Depletion on Mood
NCT01787240 (3) [back to overview]Feasibility
NCT01870843 (10) [back to overview]Change in Hamilton Anxiety Scale (HAM-A) Total Scores From Baseline up to Day 56
NCT01870843 (10) [back to overview]Change in Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) Total Scores From Baseline up to Day 56
NCT01870843 (10) [back to overview]Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores From Baseline up to Day 56
NCT01870843 (10) [back to overview]Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) From Baseline up to Day 56
NCT01870843 (10) [back to overview]Change in Sheehan Disability Scale (SDS) From Baseline up to Day 56
NCT01870843 (10) [back to overview]Depression Response Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56
NCT01870843 (10) [back to overview]Remission Rate Based on Hamilton Anxiety Scale (HAM-A) up to Day 56
NCT01870843 (10) [back to overview]Remission Rate Based on Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) up to Day 56
NCT01870843 (10) [back to overview]Remission Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56
NCT01870843 (10) [back to overview]Treatment Improvement Rate at the End of Week 1 and Week 2
NCT01876823 (10) [back to overview]Change in 24-item HAMD
NCT01876823 (10) [back to overview]Change in Selective Reminding Test - Delayed Recall (SRT-DR)
NCT01876823 (10) [back to overview]Change in Selective Reminding Test - Total Immediate Recall (SRT-IR)
NCT01876823 (10) [back to overview]Change in Trails A
NCT01876823 (10) [back to overview]Change in Trails B
NCT01876823 (10) [back to overview]Conversion to Dementia Using Clinical Dementia Rating (CDR)
NCT01876823 (10) [back to overview]Change in Clinical Global Impression - Cognitive Change
NCT01876823 (10) [back to overview]Change in Clinical Global Impression - Depression Change
NCT01876823 (10) [back to overview]Change in Treatment Emergent Side Effects (TESS)
NCT01876823 (10) [back to overview]Change in Wechsler Memory Scale-III (WMS-III)
NCT01902004 (4) [back to overview]Number of Participants With Adverse Events
NCT01902004 (4) [back to overview]Change in Montgomery Asberg Depression Rating Scale
NCT01902004 (4) [back to overview]Change in Hamilton Depression Rating Scale
NCT01902004 (4) [back to overview]Change in Cognitive Domain Scores
NCT01916824 (1) [back to overview]Money Earned
NCT01931202 (13) [back to overview]Quick Inventory of Depression Scale (QIDS-SR): Expectancy
NCT01931202 (13) [back to overview]White Matter Hyperintensity (WMH) Outcome- Total WMH
NCT01931202 (13) [back to overview]Quick Inventory of Depressive Symptoms (QIDS-SR)
NCT01931202 (13) [back to overview]Quick Inventory of Depressive Symptoms (QIDS-SR)
NCT01931202 (13) [back to overview]Quick Inventory of Depression Scale (QIDS-SR): Expectancy
NCT01931202 (13) [back to overview]Credibility and Expectancy Scale-Better (CES)
NCT01931202 (13) [back to overview]Credibility and Expectancy Scale-Depression
NCT01931202 (13) [back to overview]Credibility and Expectancy Scale-Depression
NCT01931202 (13) [back to overview]Executive Dysfunction: Stroop Color Word
NCT01931202 (13) [back to overview]Executive Dysfunction: Stroop Interference
NCT01931202 (13) [back to overview]Hamilton Rating Scale for Depression (HRSD)
NCT01931202 (13) [back to overview]Hamilton Rating Scale for Depression (HRSD)
NCT01931202 (13) [back to overview]Credibility and Expectancy Scale-Better (CES)
NCT01973283 (15) [back to overview]Hamilton Depression Rating Scale: Stratified by Baseline Frailty
NCT01973283 (15) [back to overview]Hamilton Depression Rating Scale: Stratified by Baseline Frailty
NCT01973283 (15) [back to overview]Hamilton Rating Scale for Depression (HRSD)
NCT01973283 (15) [back to overview]Hamilton Rating Scale for Depression (HRSD)
NCT01973283 (15) [back to overview]World Health Organization Disability Assessment 2.0 (36-item)
NCT01973283 (15) [back to overview]World Health Organization Disability Assessment 2.0 (36-item)
NCT01973283 (15) [back to overview]World Health Organization Disability Assessment 2.0 (36-item)
NCT01973283 (15) [back to overview]World Health Organization Disability Assessment 2.0 (36-item)
NCT01973283 (15) [back to overview]World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty
NCT01973283 (15) [back to overview]World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty
NCT01973283 (15) [back to overview]World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty
NCT01973283 (15) [back to overview]World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty
NCT01973283 (15) [back to overview]Hamilton Depression Rating Scale (HRSD)
NCT01973283 (15) [back to overview]Hamilton Depression Rating Scale: Stratified by Baseline Frailty
NCT01973283 (15) [back to overview]Hamilton Depression Rating Scale: Stratified by Baseline Frailty
NCT02080832 (4) [back to overview]fMRI Brain Activation in Right Inferior Frontal Gyrus
NCT02080832 (4) [back to overview]fMRI Brain Activation in Right Precentral Gyrus
NCT02080832 (4) [back to overview]fMRI Brain Activation in Right Orlandic Operculum
NCT02080832 (4) [back to overview]Cocaine Use/Treatment Effectiveness Score (TES)
NCT02082392 (3) [back to overview]Hamilton Rating Scale for Depression
NCT02082392 (3) [back to overview]Hamilton Anxiety Rating Scale (HARS) 14-item Scale
NCT02082392 (3) [back to overview]CGI Severity and Improvement
NCT02137369 (2) [back to overview]Number of Remission From Major Depressive Episode Events
NCT02137369 (2) [back to overview]Number of Response to Treatment Events
NCT02161458 (1) [back to overview]Amyloid Beta Levels in CSF
NCT02191397 (27) [back to overview]Number of Participants With Urinalysis Data Outside the Normal Range
NCT02191397 (27) [back to overview]Number of Participants With Suicidal Ideation or Behavior During Treatment Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
NCT02191397 (27) [back to overview]Number of Participants With Electrocardiogram (ECG) Data Outside the Clinical Concern Range
NCT02191397 (27) [back to overview]Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious AE (SAE)
NCT02191397 (27) [back to overview]Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points
NCT02191397 (27) [back to overview]Change From Baseline in Total Bilirubin, Direct Bilirubin and Creatinine at the Indicated Time Points
NCT02191397 (27) [back to overview]Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points
NCT02191397 (27) [back to overview]Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points
NCT02191397 (27) [back to overview]Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points
NCT02191397 (27) [back to overview]Change From Baseline in Hematocrit at the Indicated Time Points
NCT02191397 (27) [back to overview]Change From Baseline in HAMD-17 Sleep Disorder Subscale Score (Sum of Scores of Items 4, 5 and 6) at Weeks 1, 2, 4, 6 and 8
NCT02191397 (27) [back to overview]Change From Baseline in HAMD-17 Retardation Subscale Score (Sum of Scores of Items 1, 7, 8 and 14) at Weeks 1, 2, 4, 6 and 8
NCT02191397 (27) [back to overview]Change From Baseline in HAMD-17 Depressed Mood Subscale Score (Score of Item 1) at Weeks 1, 2, 4, 6 and 8
NCT02191397 (27) [back to overview]Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score (Sum of Scores of Items 10, 11, 12, 13, 15 and 17) at Weeks 1, 2, 4, 6 and 8
NCT02191397 (27) [back to overview]Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score at Weeks 1, 2, 4, 6 and 8
NCT02191397 (27) [back to overview]Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points
NCT02191397 (27) [back to overview]Mean Change in Hamilton Depression Rating Scale - 17 (HAMD-17) Total Score From Baseline to End of Acute Treatment Phase (Week 8)
NCT02191397 (27) [back to overview]Change From Baseline in Changes in Sexual Function Questionnaire (CSFQ)
NCT02191397 (27) [back to overview]Remission Rate Based on HAMD-17 Total Score
NCT02191397 (27) [back to overview]Number of Participants With Vital Sign Parameters Outside the Clinical Concern Range
NCT02191397 (27) [back to overview]Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points
NCT02191397 (27) [back to overview]Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Weeks 1, 2, 4, 6 and 8
NCT02191397 (27) [back to overview]Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points
NCT02191397 (27) [back to overview]Response Rate Based on HAMD-17 Total Score
NCT02191397 (27) [back to overview]Sustained Remission Rate Based on HAMD-17 Total Score
NCT02191397 (27) [back to overview]Sustained Response Rate Based on HAMD-17 Total Score
NCT02191397 (27) [back to overview]"Percentage of Participants With a Clinical Global Impression Global Improvement (CGI-I) Score of 1 (Very Much Improved) or 2 (Much Improved) at Weeks 1, 2, 4, 6 and 8"
NCT02332291 (7) [back to overview]Ruminative Response Scale (RRS)
NCT02332291 (7) [back to overview]Change in Depression Severity, Self Rated
NCT02332291 (7) [back to overview]Change in Depression Severity, Clinician Rated
NCT02332291 (7) [back to overview]Number of Patients With Remission of Depression
NCT02332291 (7) [back to overview]Change in Depression Severity, Self Rated
NCT02332291 (7) [back to overview]Change in Depression Severity, Clinician Rated
NCT02332291 (7) [back to overview]Apathy Evaluation Scale (AES)
NCT02389465 (3) [back to overview]IL-6 Levels
NCT02389465 (3) [back to overview]Montgomery Asberg Depression Rating Scale (MADRS)
NCT02389465 (3) [back to overview]IL10 Levels
NCT02417064 (16) [back to overview]Percentage of Participants Who Achieved at Least 50% Reduction From Baseline in MADRS Total Score at Day 28 of Double-blind Induction Phase (Observed Data)
NCT02417064 (16) [back to overview]Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis
NCT02417064 (16) [back to overview]Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis
NCT02417064 (16) [back to overview]Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis
NCT02417064 (16) [back to overview]Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis
NCT02417064 (16) [back to overview]Percentage of Participants in Remission (MADRS<=12) at Day 28 of Double-blind Induction Phase (Observed Data)
NCT02417064 (16) [back to overview]Percentage of Participants in Remission (MADRS<=12) at the Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis (LOCF Data)
NCT02417064 (16) [back to overview]Percentage of Participants Who Achieved at Least 50% Reduction From Baseline in MADRS Total Score at the Endpoint (Double-blind Induction Phase [Day 28]) (LOCF Data)
NCT02417064 (16) [back to overview]Percentage of Participants With Onset of Clinical Response by Day 2 and Day 8
NCT02417064 (16) [back to overview]Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score up to Endpoint (Double-blind Induction Phase [Day 28])
NCT02417064 (16) [back to overview]Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to End of Double-blind Induction Phase (Day 28): EQ-VAS
NCT02417064 (16) [back to overview]Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to End of Double-blind Induction Phase (Day 28): Health Status Index
NCT02417064 (16) [back to overview]Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to End of Double-blind Induction Phase (Day 28): Sum Score
NCT02417064 (16) [back to overview]Change From Baseline in Generalized Anxiety Disorder-7 Item (GAD-7) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])
NCT02417064 (16) [back to overview]Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 of Double- Blind Induction Phase- Mixed- Effects Model Using Repeated Measures (MMRM) Analysis
NCT02417064 (16) [back to overview]Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis
NCT02418585 (16) [back to overview]Change From Baseline in Generalized Anxiety Disorder (GAD-7) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])
NCT02418585 (16) [back to overview]Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis
NCT02418585 (16) [back to overview]Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis
NCT02418585 (16) [back to overview]Percentage of Participants With Onset of Clinical Response on Day 2 and Day 8
NCT02418585 (16) [back to overview]Percentage of Participants in Remission (SDS Total Score <=6 and Individual Item Scores Each <=2) at the End of 4-Week Double-blind Induction Phase (Day 28)
NCT02418585 (16) [back to overview]Percentage of Participants in Remission (MADRS<=12) at the Endpoint (Double-blind Induction Phase [Day 28])
NCT02418585 (16) [back to overview]Percentage of Participants Who Achieved >=50% Reduction From Baseline in MADRS Total Score at the Endpoint (Double-blind Induction Phase [Day 28])
NCT02418585 (16) [back to overview]Percentage of Participants in Response (SDS Total Score <=12 and Individual Item Scores Each <=4) at the End of 4-Week Double-blind Induction Phase (Day 28)
NCT02418585 (16) [back to overview]Change From Baseline in EQ 5D-5L-Health Status Index to End of Double-blind Induction Phase (Day 28)
NCT02418585 (16) [back to overview]Change From Baseline in EQ 5D-5L- Sum Score to End of Double-blind Induction Phase (Day 28)
NCT02418585 (16) [back to overview]Change From Baseline in EQ 5D-5L- European Quality of Life - Visual Analogue Scale (EQ-VAS) to End of Double-blind Induction Phase (Day 28)
NCT02418585 (16) [back to overview]Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 in the Double-blind Induction Phase- Mixed-Effects Model Using Repeated Measures (MMRM) Analysis
NCT02418585 (16) [back to overview]Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- Analysis of Covariance (ANCOVA) Analysis
NCT02418585 (16) [back to overview]Change From Baseline in Patient Health Questionnaire - 9-Item Depression Module (PHQ-9) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis
NCT02418585 (16) [back to overview]Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])
NCT02418585 (16) [back to overview]Change From Baseline in Patient Health Questionnaire - 9-Item Depression Module (PHQ-9) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis
NCT02422186 (8) [back to overview]Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis on Ranks
NCT02422186 (8) [back to overview]Percentage of Participants Who Achieved >=50% Reduction From Baseline in MADRS Total Score at Endpoint (Double-blind Induction Phase [Day 28]) (LOCF Data)
NCT02422186 (8) [back to overview]Percentage of Participants in Remission (MADRS<=12) at Endpoint (Double-blind Induction Phase [Day 28]) (LOCF Data)
NCT02422186 (8) [back to overview]Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- Mixed-Effects Model Using Repeated Measures (MMRM) Analysis
NCT02422186 (8) [back to overview]Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score to Endpoint (Double-blind Induction Phase [Day 28])- Analysis of Covariance (ANCOVA) Analysis
NCT02422186 (8) [back to overview]Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) to Endpoint (Double-blind Induction Phase [Day 28]): Sum Score
NCT02422186 (8) [back to overview]Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) to Endpoint (Double-blind Induction Phase [Day 28]): Health Status Index
NCT02422186 (8) [back to overview]Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) to Endpoint (Double-blind Induction Phase [Day 28]): EQ-VAS
NCT02493868 (18) [back to overview]Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Sum Score at Endpoint in Participants With Stable Remission (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in EuroQol-5 Dimension-5 Level Sum Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in Sheehan Disability Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in Generalized Anxiety Disorder-7 Items (GAD-7) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in Generalized Anxiety Disorder-7 Items Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in MADRS Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)
NCT02493868 (18) [back to overview]Time to Relapse in Participants With Stable Remission (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in MADRS Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)
NCT02493868 (18) [back to overview]Time to Relapse in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in EQ-5D-5L Health Status Index at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in PHQ-9 Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in EQ-5D-5L Health Status Index at Endpoint in Participants With Stable Remission (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in EQ-5D-5L EQ Visual Analogue Scale Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in EQ Visual Analogue Scale Score at Endpoint in Participants With Stable Remission (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in Clinical Global Impression-Severity Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)
NCT02493868 (18) [back to overview]Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Endpoint in Participants With Stable Remission (Maintenance Phase)
NCT02497287 (34) [back to overview]Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Recognition Discrimination Index
NCT02497287 (34) [back to overview]Change From Baseline in Sheehan Disability Scale (SDS) Total Score During IND Phase
NCT02497287 (34) [back to overview]Change From Baseline in Sheehan Disability Scale Total Score During OP/MA Phase
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in CGI-S Scale Score During OP/MA Phase
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in Clinical Global Impression of Severity (CGI-S) Scale Score During IND Phase
NCT02497287 (34) [back to overview]Percentage of Participants With an Increase Score From Predose at Any Time in CADSS Total Score During OP/MA Phase
NCT02497287 (34) [back to overview]Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Total Recall
NCT02497287 (34) [back to overview]Percentage of Participants With an Increase Score From Predose at Any Time in Clinician-Administered Dissociative States Scale (CADSS) Total Score During IND Phase
NCT02497287 (34) [back to overview]Percentage of Participants With Treatment-Emergent Acute Hypertension (Systolic and Diastolic) During IND and OP/MA Phases
NCT02497287 (34) [back to overview]Change From Baseline in Cognitive Test Battery: Groton Maze Learning Test (GMLT) Score
NCT02497287 (34) [back to overview]Change From Baseline in Cognitive Test Battery: Detection Test (DET) Score
NCT02497287 (34) [back to overview]Percentage of Participants With Response as Assessed by PHQ-9 Total Score During IND Phase
NCT02497287 (34) [back to overview]Percentage of Participants With Response as Assessed by MADRS Total Score During IND Phase
NCT02497287 (34) [back to overview]Percentage of Participants With Remission as Assessed by PHQ-9 Total Score During IND Phase
NCT02497287 (34) [back to overview]Percentage of Participants With Remission as Assessed by MADRS Total Score During IND Phase
NCT02497287 (34) [back to overview]Percentage of Participants With Cystitis, Urinary Tract Infections, Renal and Urinary Tract Symptoms, Renal and Urinary Disorders
NCT02497287 (34) [back to overview]Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in EQ-5D-5L Scale Score During IND Phase: Health Status Index
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in EQ-5D-5L Scale Score During OP/MA Phase: Health Status Index
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in EQ-5D-5L Score During IND Phase: EQ-VAS
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in EQ-5D-5L Score During OP/MA Phase: EQ-VAS
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in European Quality of Life (EuroQol) 5-Dimension, 5-Level (EQ 5D-5L) During IND Phase: Sum Score
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in European Quality of Life (EuroQol) 5-Dimension, 5-Level (EQ 5D-5L) During OP/MA Phase: Sum Score
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in GAD-7 Total Score During OP/MA Phase
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in Generalized Anxiety Disorder (GAD-7) Total Score During IND Phase
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in PHQ-9 Total Score During OP/MA Phase
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in MADRS Total Score During Optimization/Maintenance (OP/MA) Phase
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in Montgomery Asberg Depression Rating Scale (MADRS) Total Score During Induction (IND) Phase
NCT02497287 (34) [back to overview]Change From Baseline to Endpoint in Patient Health Questionnaire - 9 (PHQ-9) Total Score During IND Phase
NCT02497287 (34) [back to overview]Change From Baseline in Cognitive Test Battery: Identification Test (IDN) Score
NCT02497287 (34) [back to overview]Change From Baseline in Cognitive Test Battery: One Back Test (ONB) Score
NCT02497287 (34) [back to overview]Change From Baseline in Cognitive Test Battery: One Card Learning Test (OCL) Score
NCT02497287 (34) [back to overview]Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Delayed Recall
NCT02497287 (34) [back to overview]Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Number of Words Recalled
NCT02516332 (7) [back to overview]Change in Baroreflex Sensitivity, ms/mm Hg
NCT02516332 (7) [back to overview]Change in Heart Rate Variability, SDNN (Msec)
NCT02516332 (7) [back to overview]Change in Hospital Anxiety and Depression Scale (HADS), Anxiety
NCT02516332 (7) [back to overview]Change in Inflammation (C-Reactive Protein, ug/ml)
NCT02516332 (7) [back to overview]Change in Urinary Catecholamines (Epinephrine and Norepinephrine, Unit-weighted Z-score)
NCT02516332 (7) [back to overview]Change in Vascular Endothelial Function, Percentage of Dilation
NCT02516332 (7) [back to overview]Change in Lipids - Total Cholesterol, LDL (Low-density Lipoprotein), and HDL (High-density Lipoprotein); mg/dL
NCT02579343 (2) [back to overview]Change of Mean Score of the Behavioral Health Measure-20 Between Baseline and End of Study
NCT02579343 (2) [back to overview]Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks
NCT02623205 (5) [back to overview]Quantification of Brain MRGlu Without an Arterial Catheter by Training Simultaneous Estimation (SimE)
NCT02623205 (5) [back to overview]Correlation Coefficient of VersaPET Scanner From Measurements Taken at the Wrist or Ankle
NCT02623205 (5) [back to overview]Change From Baseline in Metabolic Rate of Glucose (MRGlu), Quantified Using Arterial Blood Analysis, at 8 Weeks
NCT02623205 (5) [back to overview]Change From Baseline in Hamilton Depression Rating Scale at 8 Weeks
NCT02623205 (5) [back to overview]Bias of VersaPET Scanner From Measurements Taken at the Wrist and Ankle
NCT02674529 (3) [back to overview]Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Scores
NCT02674529 (3) [back to overview]Neural Responses During the Sham Neurofeedback fMRI Task.
NCT02674529 (3) [back to overview]Change in Quick Inventory of Depressive Symptomatology (QIDS) Scores
NCT03321006 (3) [back to overview]Social Adjustment Scale Self-Report (SAS-SR) Score
NCT03321006 (3) [back to overview]Hamilton Rating Score for Depression (HRSD)
NCT03321006 (3) [back to overview]Clinical Global Impression Severity and Improvement (CGI)
NCT03388164 (2) [back to overview]Adherence Consistency
NCT03388164 (2) [back to overview]Rate of Adherence
NCT03434041 (12) [back to overview]Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Score up to the Endpoint (Double-blind Treatment Phase [Day 28])
NCT03434041 (12) [back to overview]Change From Baseline in Depressive Symptoms as Measured by the MADRS Total Score to 24 Hours Post First Dose (Day 2)
NCT03434041 (12) [back to overview]Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score to the End of Double-blind Treatment Phase (Day 28)
NCT03434041 (12) [back to overview]Change From Baseline in Participant-Reported Health Status as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score up to the Endpoint (Double-blind Treatment Phase [Day 28]): Visual Analogue Scale (VAS)
NCT03434041 (12) [back to overview]Change From Baseline in Participant-Reported Health Status as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to the Endpoint (Double-blind Treatment Phase [Day 28]): Sum Score
NCT03434041 (12) [back to overview]Change From Baseline in Participant-Reported Health-Related Quality of Life as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score up to the Endpoint (Double-blind Treatment Phase [Day 28]): Health Status Index
NCT03434041 (12) [back to overview]Change From Baseline in Sheehan Disability Scale (SDS) Total Score to the End of Double-blind Treatment Phase (Day 28)
NCT03434041 (12) [back to overview]Percentage of Participants in Remission at the End of Double-blind Treatment Phase (Day 28)
NCT03434041 (12) [back to overview]Percentage of Participants With Onset of Clinical Response
NCT03434041 (12) [back to overview]Percentage of Participants With Sustained Remission
NCT03434041 (12) [back to overview]Percentage of Responders at the End of Double-blind Treatment Phase (Day 28)
NCT03434041 (12) [back to overview]Change From Baseline in Generalized Anxiety Disorder 7-item (GAD-7) Scale Score up to the Endpoint (Double-blind Treatment Phase [Day 28])
NCT03464383 (8) [back to overview]Efficacy - Anxiety Symptoms
NCT03464383 (8) [back to overview]Adherence to Intervention
NCT03464383 (8) [back to overview]Retention
NCT03464383 (8) [back to overview]Participants Eligible for Consent Into Treatment Arms
NCT03464383 (8) [back to overview]Efficacy - Depression Symptoms
NCT03464383 (8) [back to overview]Efficacy - Depression Symptoms
NCT03464383 (8) [back to overview]Accrual
NCT03464383 (8) [back to overview]Efficacy - Anxiety Symptoms
NCT03812588 (3) [back to overview]Change From Baseline Hamilton Anxiety Rating Scale 14-item Scale
NCT03812588 (3) [back to overview]Change From Baseline Clinical Global Impressions
NCT03812588 (3) [back to overview]Change From Baseline Hamilton Rating Scale for Depression 24-Item Scale to Study Completion (8 Weeks)
NCT03924323 (5) [back to overview]Change on the Children's Global Assessment Scale (CGAS)
NCT03924323 (5) [back to overview]Response Rate on the PARS
NCT03924323 (5) [back to overview]Remission Rate on the PARS
NCT03924323 (5) [back to overview]Change on the Clinical Global Impression of Severity (CGI-S)
NCT03924323 (5) [back to overview]Change in Pediatric Anxiety Rating Scale (PARS) Severity Score
NCT03927950 (2) [back to overview]Hamilton Rating Scale for Depression
NCT03927950 (2) [back to overview]Montgomery-Asberg's Depression Rating Scale
NCT03993457 (4) [back to overview]Adverse Antidepressant Treatment Effects on CRP-consistent Antidepressant Selection Versus CRP-inconsistent Antidepressant Selection
NCT03993457 (4) [back to overview]Optional Sub-study. Validity and Reliability of Capillary Blood CRP Measurement
NCT03993457 (4) [back to overview]Efficacy of CRP-consistent Antidepressant Selection Versus CRP-inconsistent Antidepressant Selection on Remission Rates in Patients With MDD.
NCT03993457 (4) [back to overview]Efficacy of CRP-consistent Antidepressant Selection Versus CRP-inconsistent Antidepressant Selection on Improving Social and Occupational Functioning.
NCT04352101 (5) [back to overview]Snaith-Hamilton Pleasure Scale (SHAPS-C) Score
NCT04352101 (5) [back to overview]Proportion of Hard-Task Choices During the Effort-Expenditure for Rewards Task (EEfRT)
NCT04352101 (5) [back to overview]Motivation and Pleasure Scale-Self-Report (MAP-SR) Score
NCT04352101 (5) [back to overview]Inventory of Depressive Symptomatology - Self-Report (IDS-SR)
NCT04352101 (5) [back to overview]Change in Targeted Ventromedial Prefrontal Cortex-Ventral Striatal (vmPFC-VS) Functional Connectivity (FC)
NCT04476030 (16) [back to overview]Percentage of Participants With TEAEs, Graded by Severity
NCT04476030 (16) [back to overview]Change From Baseline in CGI-S Score at Day 15
NCT04476030 (16) [back to overview]Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
NCT04476030 (16) [back to overview]Percentage of Participants With MADRS Response at Day 15
NCT04476030 (16) [back to overview]Percentage of Participants With MADRS Remission at Day 15
NCT04476030 (16) [back to overview]Change From Baseline in the HAMD-17 Total Score at Day 3
NCT04476030 (16) [back to overview]Change From Baseline in the HAMD-17 Total Score Over the Double-Blind Treatment Period
NCT04476030 (16) [back to overview]Time to First HAMD-17 Response
NCT04476030 (16) [back to overview]Change From Baseline in the HAMD-17 Total Score at Days 15 and 42
NCT04476030 (16) [back to overview]Percentage of Participants With CGI-I Response, at Day 3 and Day 15
NCT04476030 (16) [back to overview]Change From Baseline in the HAMD-17 Total Score Around End of Blinded Treatment
NCT04476030 (16) [back to overview]Percentage of Participants With HAMD-17 Response at Day 15 and Day 42
NCT04476030 (16) [back to overview]Change From Baseline in MADRS Total Score at Day 15
NCT04476030 (16) [back to overview]Change From Baseline in HAM-A Total Score at Day 15
NCT04476030 (16) [back to overview]Change From Baseline in Depressive Symptoms at Day 15, as Assessed by PHQ-9
NCT04476030 (16) [back to overview]Percentage of Participants With HAMD-17 Remission at Day 15 and Day 42
NCT04697693 (1) [back to overview]Change in Hamilton Rating Score for Depression (HRSD) From Baseline to Week 8

Change in Hamilton Depression Scale

very severe, >23/29; severe, 19-22/29; moderate, 14-18/29; mild, 8-13/29; and no depression, 0-7/29 (Hamilton M., J Neurol Neurosurg Psychiatry. 1960 Feb;23:56-62.) (NCT00070941)
Timeframe: 12 weeks

,,
Interventionunits on a scale (Mean)
Baseline Visit MeasurementWeek 12 Measurement
Escitalopram17.55.3
Placebo Comparator20.716.2
SAM-e1711.4

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Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)

"OCD symptom severity was measured using the CY-BOCS, an interviewer-rated instrument that assess obsessions and compulsions separately on time consumed, distress, interference, degree of resistance, and control; it yields separate severity scores for obsessions and for compulsions (0 - 20), and a composite symptom severity score (0 to 40).~Consistent with signal detection analyses examining the optimal criterion for treatment response, a CY-BOCS reduction of 30% or more from baseline to week 12 was used as the criterion for RESPONSE and was the primary dichotomous outcome measure." (NCT00074815)
Timeframe: Measured at baseline and Week 12.

InterventionProportion of Participants with RESPONSE (Number)
MM + CBT0.69
MM + ICBT0.34
MM Only0.30

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Montgomery Asberg Depression Rating Scale (MADRS)

The Montgomery Asberg Depression Rating Scale (MADRS) is a 10 item scale for assessing the severity of depression. Items are rated on a scale of 0 to 6, so the maximum score is 60 and the minimum is 0, where 60 is the most severe depression. Scores of 18 or greater are generally considered to indicate a moderate level of depression. (NCT00086307)
Timeframe: Weekly

InterventionScore on a scale (Least Squares Mean)
Pramipexole22.629
Escitalopram26.102
Escitalopram and Pramipexole29.455

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Hamilton Rating Scale for Depression (HAM-D)

The change in total HAM-D score between baseline and endpoint was the primary outcomes measure. This measure is a clinician rated inventory of depressive symptoms. All items are scored on a scale of zero to four and the sum of the scores provides the total score for the measure. Scores can range from 0- 68. On this scale, higher scores indicate poorer outcomes. (NCT00101452)
Timeframe: baseline and 24 weeks

Interventionunits on a scale (Mean)
1. SAMe-6.7
2. Escitalopram-7.5
3. Placebo-5.7

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Quality of Life

Role -emotional impairment score from the Late-Life Function and Disability Instrument (min score=0, significant impairment; max score=100, no impairment). (NCT00105586)
Timeframe: Measured at Week 12

,
Interventionunits on a scale (Mean)
Week 0 SF-36 Role-Emotional ImpairmentWeek 12 SF-36 Role-Emotional Impairment
Escitalopram (1)42.1962.50
Placebo (2)53.4256.16

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Response Using Clinical Global Impressions-Improvement Scale (CGI-I)

Cumulative incident response of anxiety symptom improvement on CGI-I, with 1 (very much improved) to 2 (much improved) indicated as response. Scores synthesized from anxiety rating scale scores, including Penn State Worry Questionnaire (PSWQ) and Hamilton Anxiety Scale (HamA). (NCT00105586)
Timeframe: Measured at Weeks 1-12

Interventionparticipants (Number)
Placebo51
Escitalopram69

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Change in Children's Depression Rating Scale - Revised (CDRS-R) Total Score

Change from baseline to week 8 in Children's Depression Rating Scale total score. The scale measures 17 depressive symptoms, of which 3 are rated 1-5 and 14 are rated 1-7 (1 = no symptom difficulties; 5 or 7 = severe clinically significant difficulties) for a total score range of 17-113. (NCT00107120)
Timeframe: Baseline to end of week 8

InterventionChange in total score at endpoint (Mean)
Escitalopram-22.4
Placebo-18.4

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Children's Global Assessment Scale

Change from baseline to week 8 in CGAS score which rates the patient's general level of functioning for the past 14 days on a scale of 1 (most impaired) to 100 (healthiest). (NCT00107120)
Timeframe: At baseline and end of week 8

InterventionChange in score (Mean)
Escitalopram14.7
Placebo12.4

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Clinical Global Impressions - Improvement

Clinical Global Impressions - Improvement score at the end of week 8. The scale rates improvement or worsening of patient mental health relative to baseline on a scale from 1 (very much improved) to 7 (very much worse). (NCT00107120)
Timeframe: CGI-I score at the end of Week 8

InterventionScore on scale (Mean)
Escitalopram2.2
Placebo2.5

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Proportion of Patients Without Depression (Defined as a MADRS Score of 13 or Higher)

Number of patients who did not develop at any time of antiviral treatment (up to 48 weeks) a MADRS score of 13 or more as a sign of clinically relevant depression (NCT00136318)
Timeframe: Patients free of depression during 24 or 48 weeks of antiviral therapy

Interventionparticipants (Number)
Escitalopram60
Placebo40

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Severe Depression Defined as a MADRS Score of 25 or Higher

(NCT00136318)
Timeframe: severe depression during 24 or 48 weeks of antiviral therapy

Interventionpercentage of participants (Number)
Escitalopram1
Placebo12

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Sustained Virologic Response

(negative Polymerase Chain Reaction (PCR) 6 months after the end of antiviral treatment) (NCT00136318)
Timeframe: assessed 24 weeks after end of antiviral treatment

Interventionpercentage of participants (Number)
Escitalopram56
Placebo46

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Incidence of Major Depression Defined by Diagnostic and Statistical Manual IV (DSM-IV) Criteria

(NCT00136318)
Timeframe: major depression during 24 or 48 weeks of antiviral therapy

Interventionpercentage of participants (Number)
Escitalopram8
Placebo17

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Montgomery Asberg Depression Scale (MADRS) With a Score of 13 or Higher

"Clinically relevant depression (MADRS score of 13 or higher) during antiviral treatment presented as percentage of participants with MADRS scores > 13 (entire time period: from starting study medication until end of antiviral treatment = 48 weeks in patients with genotype 1 or 4 and 24 weeks for patients with genotype 2 or 3)" (NCT00136318)
Timeframe: 50 weeks for genotypes 1 or 4 and 26 weeks for patients with genotype 2 or 3

Interventionpercentage of participants (Number)
Escitalopram32
Placebo59

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Phase I Response to Escitalopram (as Measured by the BDD-YBOCS)

We calculated the proportion of patients who achieved response in Phase I, defined as a >=30% reduction in BDD-YBOCS total score from baseline through the last phase 1 visit. (NCT00149799)
Timeframe: Phase I: Weekly for weeks 1-4, biweekly from weeks 6-14

Interventionpercentage of subjects who responded (Number)
Phase I: Open-Label Escitalopram67

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Change in Quality of Life (Q-LES-Q-SF) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)

Subjects switched to placebo were compared to those remaining on escitalopram (double-blinded randomization) to assess quality of life changes as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF). The Q-LES-Q-SF is designed to help assess the degree of enjoyment and satisfaction experienced during the past week across several domains: social, leisure, household, work, emotional well-being, physical, and school; it consists of 5-point rater-administered questions. Raw scores can range from 14-70, which are converted to percentage maximum possible by calculating: % Max = (Raw-minimum score)/(maximum score-minimum score). Q-LES_Q-SF percent scores can range from 0-100, with higher scores indicating greater quality of life and satisfaction. (NCT00149799)
Timeframe: Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)

,
InterventionPercentage score (Mean)
Week 14Week 28Week 40
Phase II: Escitalopram74.178571470.272727369.0833333
Phase II: Placebo70.925925967.368421168.6470588

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Change in Functional Impairment Symptoms (LIFE-RIFT) Over Double-blind Relapse Prevention Phase of the Trial (Phase II)

Subjects switched to placebo were compared to those remaining on escitalopram (double-blind randomization) to assess functional impairment as measured by the Longitudinal Interval Followup Evaluation - Range of Impaired Functioning Tool (LIFE-RIFT). The tool assesses psychosocial functioning in multiple domains, consisting of 5- to 7-point clinician administered scales that obtain information about work, household duties, student work, relationships with family and friends, recreation, life satisfaction, and global social adjustment. Scores can range from 3-22 with higher scores indicating poorer functioning. (NCT00149799)
Timeframe: Measured three times throughout phase 2 of study (Weeks 14, 28 and 40)

,
Interventionunits on a scale (Mean)
Week 14Week 28Week 40
Phase II: Escitalopram9.00000009.80000009.7600000
Phase II: Placebo8.24137939.00000008.8947368

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Change in Depression Symptoms (HAM-D) During the Double-blind Relapse Prevention Phase of the Trial (Phase II)

Depressive symptoms were assessed with the Hamilton Rating Scale for Depression (HAM-D), a widely used 21-item depression scale. Of the 21 items on the scale, only the first 17 are used to calculate the total score. Eight of these items are scored on a 5-point scale, ranging from 0 (not present) to 4 (severe symptom), and nine are scored from 0-2. The total score ranges from 0 to 50, where higher scores indicate a greater severity of depression and scores greater than 19 are generally considered indicative of severe depression. (NCT00149799)
Timeframe: Measured bi-weekly in phase 2 from week 14 (start of randomization for relapse prevention) to week 40

,
Interventionunits on a scale (Mean)
Week 14Week 16Week 18Week 20Week 22Week 24Week 26Week 28Week 30Week 32Week 34Week 36Week 38Week 40
Phase II: Escitalopram3.53571433.89285715.28571434.84615384.23076923.6253.86956524.482.852.95652173.3754.04166673.81818184.2400000
Phase II: Placebo3.37931034.23333336.37037045.42857143.74074073.77272734.044.40909094.54545454.24.75.43.46666674.1578947

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Phase II Relapse of Body Dysmorphic Disorder (BDD) Symptoms (as Measured by the BDD-YBOCS)

We compared the rate of relapse (accounting for time from randomization to relapse and censoring) by treatment arm in Phase II. (NCT00149799)
Timeframe: Phase II: Biweekly for six months after randomization

Interventionpercentage of subjects who relapsed (Number)
Phase II: Escitalopram18
Phase II: Placebo40

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Remission of Depression (%)

"Percent of participants in depressive remission at 12 weeks. Remission of depression was required both an HRSD score ≤ 7 and absence of the two core symptoms of MDD based on the depression module of the SCID.~The HRSD (Hamilton Rating of Depression Scale) measure depressive symptom severity. TIt has 17 items. The score ranges between 0 and 48. A score below 7 represents minimal symptoms.~The SCID rates 9 symptoms of depression as present or absent. The two core symptoms of depression are sadness and anhedonia (low motivation and/or enjoyment in significant life domains)." (NCT00149825)
Timeframe: After 12 weeks or at the last available time point

Interventionpercent of participants (Number)
MED+CBTI61.5
MED+CTRL33.3

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Remission of Insomnia

Percent of participants in insomnia remission. Remission of insomnia was defined by an Insomnia Severity Index (ISI)score < 8. The ISI (Insomnia Severity index) scores range between 0 and 38. A score < 8 indicates absence of insomnia. (NCT00149825)
Timeframe: After 12 weeks or at the last available time point

Interventionpercent (Number)
MED+CBTI50.0
MED+CTRL7.7

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Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week8

"Number of subjects that showed no response, partial response, and response based on scores from baseline and week 8.~The 21-item HDRS measures depression severity. The scoring is sum the total of all 21 items to arrive at the total score, with a range of 0 to 60, where higher scores indicated greater severity. Nine items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Eleven items are scored from 0 - 2 (0 = absent and 2 = severe). The last item is scored on a 4-point scale of 0-3 (0 = absent and 3 = severe). The HDRS at week 8 was compared to the baseline HDRS and each participant's response was calculated using the below table:~No Response = < 25% change in Depression Rating Scale Score Partial Responder = < 50% to >25% change in Depression Rating Scale Score Responder = 50% or greater change in Depression Rating Scale Score" (NCT00166114)
Timeframe: Baseline, Week 8

,
Interventionparticipants (Number)
ResponseNo or Partial Response
Desipramine94
Escitalopram52

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Total Score in the Montgomery-Asberg Depression Rating Scale

"The MADRS is a 10-item scale, clinician-administered, which is sensitive to symptom change during antidepressant treatment. It has been frequently used to measure depressive symptoms during interferon-alpha therapy and exhibits improved internal consistency in patients with co-morbid medical conditions compared with other clinician-administered questionnaires.~Items are rated on a scale of 0-6. Scores range from 0 to 60, higher scores meaning higher levels of depression." (NCT00166296)
Timeframe: 12 weeks after interferon treatment onset

InterventionScores on a scale (Mean)
Escitalopram3.82
Placebo4.38

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Total Score in the Depression Subscale of the Hospital Anxiety and Depression Scale.

"The Hospital Anxiety and Depression Scale (HADS) is 14-item scale, patient-administered, that allows two independent scores of depression and anxiety. It has been specially designed to apply in patients with comorbid medical conditions as it excludes somatic or vegetative symptoms from the depression subscale.~We present data of de depression subscale. The seven-item Depression subscale yields a score of 0-21, with higher scores meaning higher levels of depressive symptoms." (NCT00166296)
Timeframe: 12 weeks after interferon treatment onset

InterventionScores on a Scale (Mean)
Escitalopram2.25
Placebo2.13

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Number of Participants With Sustained Hepatitis C Viral Response (Negativization of Serum Hepatitis C Virus Ribonucleic Acid).

"Number of participants with negativization of serum hepatitis C Virus Ribonucleic Acid (HCV RNA) 6 months after concluding antiviral therapy (sustained viral response).~Negativization was defined as the absence of detectable levels of serum HCV RNA using a polymerase chain reaction." (NCT00166296)
Timeframe: Six months after the end of interferon treatment

InterventionParticipants (Number)
Escitalopram36
Placebo38

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Number of Participants Who Developed a Major Depressive Episode According to Diagnostic & Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Criteria During the First 12 Weeks of Antiviral Treatment.

"At least five of the symptoms have been present during the same 1-week period: depressed mood, loss of interest or pleasure, weight or appetite changes, insomnia, agitation or retardation, fatigue, feelings of worthlessness or guilt, diminished ability to think or concentrate, recurrent thoughts of death.~At least one of the symptoms is either depressed mood or loss of interest. Diagnoses were made by a trained psychiatrist who applied the mood disorders module from the Structured Clinical Interview for DSM-IV Axis I Disorders, non-patient edition (SCID-I/NP) at each study evaluation." (NCT00166296)
Timeframe: First three months of interferon treatment.

InterventionParticipants (Number)
Escitalopram5
Placebo2

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Change in PSG Sleep Efficiency for the Second Night in the Sleep Lab at Each Timepoint

Change in PSG Sleep Efficiency (SE) between post-treatment and baseline: Sleep efficiency is the percent of time spent asleep divided by the total sleep recording period in the sleep lab. This value is calculated using the results of the polysomnographic sleep study. It ranges from 0 (no sleep at all) to 100 (asleep the second the sleep recording starts (GNT) until the sleep recording ends (GMT) in the morning). The values below are post treatment SE minus pre treatment SE. A positive number means that the SE was higher (better) post treatment. (NCT00177216)
Timeframe: post treatment minus baseline PSG sleep studies. This averaged 70 days

Interventiondifference score for SE (Mean)
Zolpidem0.43
Escitalpram1.16
Placebo0.32

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Change in Pittsburgh Sleep Quality Index

Self-report measure of sleep quality developed at University of Pittsburgh by Daniel J. Buysse, M.D. The PSQI total score ranges from 0 to 21 with 0 being marvelous sleep and 21 being horrid sleep. The difference score, reported below, is the total score after at least 5 weeks of treatment in one of the three arms, minus the baseline total score. A negative score means that the sleep of the participant improved. (NCT00177216)
Timeframe: post treatment minus baseline assessment battery. This averaged 100 days.

Interventiondifference score of PSQI total (Mean)
Experimental: Zolpidem-0.86
Experimental: Excitalopram-3.15
Placebo Comparator: Placebo-3.32

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Change in Diary Sleep Efficiency

The change in self-report sleep efficiency calculated from 7-day sleep diary (DSE): Sleep efficiency is the percent of (time spent asleep divided by the amount of time between good night time and final awakening). It ranges from 0 (no sleep at all) to 100 (asleep the second your head hits the pillow until you wake up in the morning and get out of bed). Participants report the time they go to bed, how long they think it takes them to fall asleep, how many minutes they are awake during the night, and then what time they finally wake up in the morning. These values are used to calculate the diary sleep efficiency for each night and then we averaged these across the 7 days of diary collected pre and post treatment. The values below are post treatment DSE minus pre treatment DSE. A positive number means that the DSE was higher (better) post treatment. (NCT00177216)
Timeframe: post treatment minus baseline. This averaged 69 days.

Interventiondiff score of diary Sleep Efficiency (Mean)
Zolpidem3.20
Escitalopram0.61
Placebo4.87

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Remission

Three consecutive weekly scores of less than 7 on the Hamilton Rating Scale for Depression (N=17 item). Scores on the Hamilton Rating Scale for Depression(HRSD) range from 0 to 58, with higher scores indicating more severe depression. (NCT00177294)
Timeframe: Measured at Week 6 or 22

InterventionPercentage of participants (Number)
Escitalopram Plus Interpersonal Psychotherapy (IPT)58
Escitalopram Plus Depression Care Management (DCM)45

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Number of Participants With Recurrence of Major Depression

Recurrence of major depressive episodes as determined by SCID/DSM IV: two weeks of low mood and/or anhedonia, together with at least five of the following symptoms: suicidal ideation, low energy, sleep disturbance, appetite disturbance, psychic anxiety or somatic anxiety. In addition, a diagnosis of major depression requires evidence of distress or impairment. (NCT00177671)
Timeframe: 2 years

Interventionparticipants (Number)
Donepezil19
Placebo11

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Percentage of Participants With Mild Cognitive Impairment Converting to Dementia.

Conversion to dementia was ascertained by the University of Pittsburgh Alzheimer Disease Research Center (ADRC), using data on neuropsychological performance and IADL functioning, as well as other relevant clinical data. Diagnoses were made according to National Alzheimer Coordinating Center criteria. (NCT00177671)
Timeframe: 2 year

InterventionPercent of Participants (Number)
Donepezil10
Placebo33

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Cognitive Instrumental Activities of Daily Living (IADL)

The PASS (a performance-based assessment of instrumental activities of daily living)generates a composite measure of 13 cognitive IADL items capturing performance on activities such as shopping, bill paying, medication management, and home safety. We report the percentage of subjects at each assessment point adjudged to have independent functioning. This was determined by a clinician rater observing subjects perform each task and rating them according to predetermined criteria on a 4 point scale, ranging from 0 (unable) to 3 (independent). (NCT00177671)
Timeframe: baseline, year 1 and year 2

,
InterventionPercentage of participants (Number)
Baseline (N=33; N=34)Year 1 (N=23; N=25)Year 2 (N=11; N=17)
Donepezil54.1062.1636.67
Placebo61.8254.3547.22

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Global Cognitive Performance

Cognitive performance was assessed with 17 well established and validated individual tests measuring multiple domains. We transformed raw scores for individual tests into Z-scores using the baseline distribution of a non-depressed, cognitively normal, older adult comparison group (N=36)of similar age, education, and medical health recruited concurrently with the depressed participants. These Z-scores were averaged within each neuropsychological area to produce domain scores and then averaged over all 17 tests to calculate a global cognition performance score. (NCT00177671)
Timeframe: Measured at baseline and Years 1 and 2 in maintenance

,
InterventionZ-score (Mean)
Baseline (N=67;N=63)Year 1 (N=45; N=57)Year 2 N=42; N=49)
Donepezil-0.47-0.23-0.31
Placebo-0.47-0.65-0.56

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Responder and Remission Status (%), Based on the Depression Rating Scale Score

The Hamilton Depression Rating Scale, 17 items (HAMD-17, range 0-52) was used to measure changes in depression severity from baseline to endpoint. Clinical Responder status was defined as > 50% improvement (i.e., reduction) in HAMD-17 score from baseline to endpoint. Clinical Remission status was defined as HAMD-17 score < 8 at endpoint (week 12 visit). (NCT00183677)
Timeframe: Measured at Week 12

Interventionparticipants (Number)
Clinical RespondersClinical Remitters
Open Label Escitalopram3632

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Average Change in 3 Weeks of Participant Treatment Expectations

Patient Attitudes and Expectations Form used for assessing expectation. The California Pharmacotherapy Alliance Scale, a measure associated with outcomes of antidepressant pharmacotherapy, used to measure participants' perceptions of: (a) participants' commitment to treatment; (b) participants' working capacity; (c) treatment providers' understanding and involvement; and (d) goal and working strategy consensus between participant and treatment provider. This is a 24-item questionnaire with a 7-point Likert scale (1 = not at all, 7 = very much so). Total score ranges from a minimum of 0 and a maximum of 120. The score is determined by a combination of negative and positive items. To assure negative items are reflected, subtract each of the negative item ratings from 8; for example, a rating of 1 becomes 7 (8 minus 1). The scores are computed by summing the items and dividing the total by 6 to procure the mean rating. A lower score indicates a worse outcome. (NCT00200902)
Timeframe: Averaged over 3 time points (Baseline, randomization, and end of lead-in)

Interventionunits on a scale (Mean)
Medication (MED)3.55
Placebo (PBO)3.94
Interpersonal Clinical Interaction (ICI)3.17

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Change in Hamilton Depression Assessment Score

Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression/worse outcome. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52. (NCT00200902)
Timeframe: Baseline,Week 8

,,
InterventionHAMD score (Mean)
Percent Change in HAM-DChange in HAM-D
Interpersonal Clinical Interaction (ICI)-0.05-1.37
Medication (MED)-0.46-10.05
Placebo (PBO)-0.36-7.59

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Response as Assessed by Participants' Change in Depression Rating

Comparison of treatment arms (Medication + ICI, Placebo+ICI, and ICI only). The Hamilton Depression Rating Scale (HAM-D-17) used here is a 17-item scale that measures severity of depression. Items are individually scored from 0-4 or from 0-2 depending on the item, and the individual scores for each item are added to comprise one score. Higher scores indicate greater severity of depression. Possible scores on the scale range from a minimum of zero (0) to a maximum of 52.Response is defined as a 50% decrease in HAMD-17 scoring. Remission defined as a HAMD-17 score of 7 or less. (NCT00200902)
Timeframe: Baseline, Week 8

,,
InterventionParticipants (Count of Participants)
RespondersRemitters
Interpersonal Clinical Interaction (ICI)10
MEDICATIONS179
Placebo (PBO)119

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Response of Participants, Defined by Change in the 21-item Hamilton Depression Rating Scale (HDRS) From Baseline to Week 24

"The 21-item HDRS measures depression severity. Items are rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score range of 0 to 60, where higher scores indicate greater severity. The HDRS at week 24 was compared to the baseline HDRS and each participant's response was calculated using the below table:~No Response = < 25% change in Depression Rating Scale Score Partial Responder =< 50% to >25% change in Depression Rating Scale Score Responder = 50% or greater change in Depression Rating Scale Score" (NCT00209170)
Timeframe: Baseline, week 24

,
Interventionparticipants (Number)
ResponsePartial ResponseNo Response
Beating the Blues CBT + Escitalopram223
Beating the Blues CBT + Placebo115

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Yale Brown Obsessive Compulsive Scale

The Yale Brown Obsessive Compulsive Scale (YBOCS) is a clinician administered measure of the severity of obsessive compulsive disorder(OCD). Higher scores indicate a greater severity of OCD symptoms. The score can range from a minimum of zero to a maximum of forty. (NCT00215137)
Timeframe: Open Label Phase Baseline,Randomization Phase Baseline or Beginning

,,
Interventionunits on a scale (Mean)
Beginning of Study PhaseEnd of Study Phase
Open Label Escitalopram24.7915.36
Randomization Escitalopram16.0015.8
Randomization Placebo12.7120.17

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Change in Clinical Global Impressions-Severity Index

7 point scale of overall severity of psychopathology from 1 mildest to 7 most severe. (NCT00219349)
Timeframe: week 14 to week 26

Interventionunits on a scale (Mean)
Patients Who Started Escitalopram1.4

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Change in Beck Depression Inventory-II

total score ranges from 0 (not depressed) to 63 (most severe) (NCT00219349)
Timeframe: week 14 to week 26

Interventionunits on a scale (Mean)
Patients Who Started Escitalopram10.7

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Change in Hamilton Anxiety Rating Scale Score

The Hamilton Anxiety Rating Scale is a clinician administered rating scale assessing severity of anxiety from 0 (low) to 64 (high). The greater the magnitude of decrease in score during treatment, the greater the improvement in anxiety. (NCT00219349)
Timeframe: week 14 to week 26

Interventionunits on a scale (Mean)
Patients Who Started Escitalopram-6.4

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Change in Hamilton Rating Scale for Depression

24 item version of this standard depression scale, total score ranges from 0 (not depressed) to 58 (most severe) (NCT00219349)
Timeframe: week 14 to week 26

Interventionunits on a scale (Mean)
Patients Who Started Escitalopram7.3

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Change in Penn State Worry Questionnaire

total score (of 16 items) ranging from 16 (least worry) to 80 (most worry) (NCT00219349)
Timeframe: week 14 to week 26

Interventionunits on a scale (Mean)
Patients Who Started Escitalopram9.8

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Change in State-Trait Anxiety Inventory, State Subscale

only the total score of the state anxiey subscale was used. Range is from 20 (mildest) to 80 (most severe) (NCT00219349)
Timeframe: week 14 to week 26

Interventionunits on a scale (Mean)
Patients Who Started Escitalopram15.4

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Clinical Global Impressions-Improvement Index

This is a single item rating overall symptomatic improvement. Range is 0 (very much worse) to 7 (very much improved) (NCT00219349)
Timeframe: week 26

Interventionunits on a scale (Mean)
Patients Who Started Escitalopram3.0

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Change in Generalized Anxiety Disorder Severity Scale

measures severity of symptoms of generalized anxiety disorder, reported as a total score summing 10 items that are each rated from 0, never to 4, all of the time. Range is 0 to 40, with 40 most severe. (NCT00219349)
Timeframe: week 14 to week 26

Interventionunits on a scale (Mean)
Patients Who Started Escitalopram4.8

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Beck Depression Inventory (BDI)

21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression. (NCT00220701)
Timeframe: Week 12

Interventionunits on a scale (Mean)
Escitalopram6.76
Placebo10.00

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Beck Depression Inventory (BDI)

21 item patient rated assessment of depression symptoms, with item scores ranging from 0 to 3. Total BDI scores can range from 0 to 63, with higher scores indicating worse depression. (NCT00220701)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Escitalopram15.00
Placebo16.25

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Hamilton-Depression Rating Scale (HDRS-24 Items)

Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7) (NCT00220701)
Timeframe: Week 12

Interventionunits on a scale (Mean)
Escitalopram10.88
Placebo16.41

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Hamilton-Depression Rating Scale (HDRS-24 Items)

Clinician rated measure of depression, mean score; This study used the 24 item version of the Hamilton Depression Rating Scale; item scores range from 0 to 4 on some items, 0 to 2 or 0 to 3 on other items; range of total score = 0 to 75, with higher score indicating worse depression Response (>50% decrease) Remission (score<=7) (NCT00220701)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Escitalopram22.82
Placebo24.41

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Clinical Global Impressions - Severity (CGI-S)

Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology) (NCT00220701)
Timeframe: Week 12

Interventionunits on a scale (Mean)
Escitalopram2.35
Placebo3.41

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Clinical Global Impressions - Severity (CGI-S)

Clinician rated severity, score on CGI-S scale ranging from 1 (no pathology) to 7 (extreme pathology) (NCT00220701)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Escitalopram4.06
Placebo4.06

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Dyspepsia-Specific Quality of Life

The Nepean Dyspepsia Index (NDI) assessed quality of life. NDI scores are summarized into overall quality of life and 5 subscales: Interference, Knowledge/Control, Eating/Drinking, Sleep Disturbance, Work/Study. The scale consists of 25 items, yielding 5 sub-scales. Range 0-100, higher numbers indicate a greater quality of life. (NCT00248651)
Timeframe: 12 Weeks

,,
Interventionunits on a scale (Mean)
Overall Quality of LifeInterference SubscaleKnowledge/Control SubscaleEat/Drink SubscaleSleep Disturbance SubscaleWork/Study Subscale
Amitriptyline80.683.278.272.486.386.9
Escitalopram82.882.876.270.680.887.2
Placebo73.576.272.964.876.479.7

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Maximum Tolerated Volume by Nutrient Drink Test

The nutrient drink test for meal-induced satiety had subjects drink 120 ml of ENSURE every four minutes. Satiety scores were measured on a scale graded 0-5 (1, no symptoms; 5, maximum satiety). When a score of 5 was reached, the maximum tolerated volume intake was measured. Abnormal satiety was defined as inability to consume > 800 ml of Ensure. (NCT00248651)
Timeframe: 12 weeks

Interventionml (Mean)
Amitriptyline764
Escitalopram823
Placebo839

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Gastric Emptying Half-Time (T1/2)

The time for half of the ingested solids or liquids to leave the stomach. (NCT00248651)
Timeframe: 12 weeks

Interventionminutes (Mean)
Amitriptyline117
Escitalopram108
Placebo115

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Self-Report of Adequate Relief of Dyspepsia (Yes/No) For at Least 50% of Weeks 3 -12 of Treatment

The first two weeks of treatment were excluded to allow for establishment of steady state drug levels. (NCT00248651)
Timeframe: 3 weeks through 12 weeks

Interventionpercentage of participants (Number)
Amitriptyline53
Escitalopram38
Placebo40

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Number of IL-2 Treatments Tolerated

The mean number of IL-2 doses tolerated (out of the possible 60 total doses) are presented for each study arm. The standard high dose regimen of IL-2 includes 15 doses per cycle. The dose of IL-2 is reduced, or treatment is stopped entirely, if the side effects become severe. This analysis includes the total number of doses taken at the end of Cycle 4, by all participants who began the trial, regardless of how many cycles each participant completed. (NCT00352885)
Timeframe: Cycle 4 (up to 12 weeks of IL-2 treatment)

InterventionIL-2 treatments (Mean)
Escitalopram18.4
Placebo19.8

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Hamilton Depression Rating Scale (HAM-D) Score

Hamilton Depression Rating Scale (HAM-D) is a 21-item, observer-rated scale which quantifies the severity of depressive symptoms, including depressed mood, loss of interest in usually pleasurable activities, insomnia, anorexia, fatigue, weight loss, and psychomotor retardation or agitation. Participants rate the severity of their symptoms on a scale of 0-2 or 0-4 (depending on the item), where 0 means that the symptom is absent. Total scores are calculated by summing the first 17 items for a total score between 0 and 50. For this study a score of 0-6 indicates a normal state, a score of 7-17 indicates mild depression, a score of 18-24 indicates moderate depression, and a score of greater than 25 indicates severe depression. The HAM-D was administered at screening (baseline value) and once during days 1-3 of each cycle of the four IL-2 treatments. (NCT00352885)
Timeframe: Screening and Cycles 1 - 4 (up to 14 weeks)

,
Interventionunits on a scale (Mean)
ScreeningCycle 1Cycle 2Cycle 3Cycle 4
Escitalopram7.7711.5612.3314.5614.56
Placebo6.4512.7315.0016.6416.00

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Plasma Concentrations of Adrenocorticotropic Hormone (ACTH)

Adrenocorticotropic hormone (ACTH) is a stress hormone that is synthesized by the pituitary in response to corticotropin-releasing hormone (CRH). ACTH stimulates adrenal cortisol production. ACTH levels vary throughout the day and are highest between 6am and 8am. A typical reference range is 10-50 picograms per milliliter (pg/ml) from blood drawn in the morning. Low levels of ACTH can indicate adrenal insufficiency (including adrenal cancers) while high levels may indicate several diseases or stress. IL-2 treatment stimulates the release of ACTH and this stimulation is dose dependent (rising as the dose of IL-2 increases) and tends to increase further with repeated exposure to IL-2. Blood was drawn for measuring ACTH at screening (baseline value) and once during days 1-3 of each cycle of the four IL-2 treatments. (NCT00352885)
Timeframe: Screening and Cycles 1 - 4 (up to 14 weeks)

,
Interventionpg/ml (Mean)
ScreeningCycle 1Cycle 2Cycle 3Cycle 4
Escitalopram27.5545.66112.5987.8991.25
Placebo28.9556.6075.69136.1381.23

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Plasma Concentrations of Interleukin 6 (IL-6)

Immune system functioning was assessed by measuring plasma concentrations of interleukin 6 (IL-6). IL-6 is a proinflammatory cytokine that is elevated during times of inflammation, infection, in patients with advanced or metastatic cancer, and is also implicated in mood disorders. IL-2 treatments are associated with increased IL 6 levels, in a dose response manner. IL-6 values in healthy individuals are generally less than 16 pg/ml. Blood was drawn for measuring IL-6 at screening (baseline value) and once during days 1-3 of each cycle of the four IL-2 treatments. (NCT00352885)
Timeframe: Screening and Cycles 1 - 4 (up to 14 weeks)

,
Interventionpg/ml (Mean)
ScreeningCycle 1Cycle 2Cycle 3Cycle 4
Escitalopram11.68290.77210.90305.41283.34
Placebo10.12270.11297.94332.49308.09

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Plasma Concentrations of Cortisol

Cortisol is a steroid hormone made in the adrenal glands in response to fear or stressful situations. A typical reference range is 6-23 micrograms/deciliter (mcg/dL) from blood drawn in the morning. Low levels of cortisol can indicate Addison's disease or a problem with the pituitary gland, while high levels may indicate tumors of the adrenal gland, among other illnesses, or increased stress. Chronic elevation of cortisol is associated with reduced immune function and increased risk of heart disease. IL-2 treatment stimulates the release of cortisol and this stimulation is dose dependent (rising as the dose of IL-2 increases) and tends to increase further with repeated exposure to IL-2. Blood was drawn for measuring cortisol at screening (baseline value) and once during days 1-3 of each cycle of the four IL-2 treatments. (NCT00352885)
Timeframe: Screening and Cycles 1 - 4 (up to 14 weeks)

,
Interventionmcg/dL (Mean)
ScreeningCycle 1Cycle 2Cycle 3Cycle 4
Escitalopram11.5120.6019.5322.4420.58
Placebo10.6217.7818.4619.1118.86

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Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, in Intent to Treat Sample

"Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the last observation:~Non-response: <30% reduction from baseline~Partial Response: 30-49% reduction from baseline~Response without remission: ≥50% reduction from baseline, but HDRS-17 score >7~Remission: HDRS score ≤7" (NCT00360399)
Timeframe: Up to 12 Weeks

,,
Interventionparticipants (Number)
Non-ResponsePartial ResponseResponse without remissionRemission
Cognitive Behavioral Therapy (CBT)32191044
Duloxetine21161158
Escitalopram26121849

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Remission From Major Depressive Episode Among Participants Who Completed the Intervention

The percentage of participants who achieved remission from a major depressive episode. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) after 10 weeks and 12 weeks of the assigned study treatment was considered to be remission from depression. (NCT00360399)
Timeframe: Measured at Weeks 10 and 12

Interventionpercentage of participants (Number)
Escitalopram44.2
Duloxetine51.9
Cognitive Behavioral Therapy (CBT)43.5

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Number of Participants Achieving Remission From Major Depressive Episode After 12 Weeks of Combined Treatment, for Those Patients Who do Not Achieve Remission With Monotherapy

The number of participants achieving remission from major depressive episode after 12 weeks of combined treatment consisting of antidepressant plus cognitive behavioral therapy (CBT) treatments. Those originally randomized to receive one of the antidepressants remained on that medication and had CBT sessions added. Participants originally randomized to CBT had escitalopram added at a dose of 10 to 20 mg per day for 12 weeks (NCT00360399)
Timeframe: Measured after 12 weeks of combined treatment

Interventionparticipants (Number)
Escitalopram22
Duloxetine10
Cognitive Behavioral Therapy (CBT)18

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Remission From Major Depressive Episode in Intent to Treat Sample

The percentage of participants who achieved remission from a major depressive episode, using a last observation carried forward (LOCF) dataset, defined as all randomized patients who initiated treatment and had at least one follow-up rating assessment. A score of equal to or greater than 7 on the Hamilton Depression Rating Scale (HDRS) at the last observation was considered to be remission from depression. (NCT00360399)
Timeframe: Up to 12 Weeks

Interventionpercentage of participants (Number)
Escitalopram46.7
Duloxetine54.7
Cognitive Behavioral Therapy (CBT)41.9

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Number of Participants Experiencing Depression Recurrence Following Remission to Monotherapy Treatment

The number of participants experiencing a recurrence of depression after they had been in remission with the monotherapy treatment they were randomized to receive. (NCT00360399)
Timeframe: Measured at 6, 9, 12, 15, 18, 21, and 24 months

,,
Interventionparticipants (Number)
6 Months9 Months12 Months15 Months18 Months21 Months24 Months
Cognitive Behavioral Therapy (CBT)1135555
Duloxetine0224455
Escitalopram0111233

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Number of Participants in Each Category of Response to Treatment of Depressive Symptoms, Among Participants Who Completed the Intervention

"Four mutually exclusive categorical outcomes were defined based on the last valid Hamilton Depression Rating Scale (HDRS) rating at the Week 10 and Week 12 visits:~Non-response: <30% reduction from baseline~Partial Response: 30-49% reduction from baseline~Response without remission: ≥50% reduction from baseline, but HDRS-17 score >7~Remission: HDRS score ≤7" (NCT00360399)
Timeframe: Measured at Weeks 10 and 12

,,
Interventionparticipants (Number)
Non-ResponsePartial ResponseResponse without remissionRemission
Cognitive Behavioral Therapy (CBT)15131130
Duloxetine10121641
Escitalopram15102338

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Serum Brain-derived Neurotrophic Factor (BDNF) Levels

"Pre-SSRI BDNF Level refers to the data collection point before SSRI intake and Post-SSRI BDNF Level refers to the data collection point 8 weeks after SSRI intake." (NCT00361218)
Timeframe: 8 weeks

Interventionpg/mL (Mean)
Pre-SSRI BDNF LevelPost-SSRI BDNF Level
Open-label Selective Serotonin Reuptake Inhibitor (SSRI)6077.2704393.24

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Remission Defined as Hamilton Depression Rating Scale-17 Score of Less Than or Equal to 7 at 12 Weeks

# of study participants with Hamilton Depression-17-item score less than or equal to 7. (NCT00367341)
Timeframe: Measured at week 12

Interventionparticipants (Number)
Escitalopram12
Cognitive Behavioral Therapy12

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Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks

Number of participants with a 50% change from Baseline on the Hamilton Depression Rating Scale-17-item score (NCT00367341)
Timeframe: Measured at week 12.

Interventionparticipants (Number)
Escitalopram18
Cognitive Behavioral Therapy18

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Side Effect Burden

Side efect burden was defined as the total score of the UKU Side Effects Rating Scale. This scale contains 48 items corresponding to side effects which are rated from 0-3, with 0 meaning not present and 1-3 rating the severity of the side effect. Higher scores represented greater side effect burden. The scale range is 0 to 144. (NCT00387348)
Timeframe: 4 weeks

Interventionunits on a scale (Mean)
Placebo-Placebo3.00
Placebo-Escitalopram2.50
Escitalopram-Placebo3.44

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Depression Response Rate of Escitalopram Oxalate 10 mg Once Daily Compared to Placebo Once Daily for Major Depressive Disorder

Response rate was defined as a 50% reduction in the Hamilton Depression Rating Scale (HAM-D) scores over 4 weeks. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range. (NCT00387348)
Timeframe: 4 weeks

Interventionnumber of participants with response (Number)
Placebo-Placebo3
Placebo-Escitalopram1
Escitalopram-Placebo6

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Change in Hamilton Depression Rating Scale (HAM-D) Scores

The change in HAM-D scores was calculated by subtracting the score at 4 weeks from the score at baseline. The HAM-D can have total scores that range from 0 to 50, with higher scores indicating greater depression. Scores over 14 are considered to be in the depressed range. (NCT00387348)
Timeframe: 4 weeks

InterventionChange in HAM-D scores (Mean)
Placebo-Placebo6.23
Placebo-Escitalopram10.60
Escitalopram-Placebo6.45

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Hamilton Depression Scale (HAM-D)

Hamilton Depression Scale, 21 item version Summary of all 21 items and higher score means worse depression. Scores range from 0 to a maximum of 63. (NCT00404755)
Timeframe: 6 weeks or last visit in Phase

Interventionunits on a scale (Mean)
Bupropion11.2
Escitalopram9.7
Imipramine11.3

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Clinical Global Impression Scale (CGI)

"The CGI is a standard measure of global psychopathology. CGI-severity scores rated on a 7-point scale, with the severity of illness scale using a range of responses from~1 (normal) through to 7 (amongst the most severely ill patients). CGI-improvement scores range from 1 (very much improved) through to 7 (very much worse)." (NCT00404755)
Timeframe: 6 weeks or last visit in Phase

Interventionunits on a scale (Mean)
Bupropion2.65
Escitalopram2.73
Imipramine2.67

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Clinical Global Impression Improvement (CGI-I) Score at 8 Weeks

CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1= very much improved; 7= very much worse). (NCT00406640)
Timeframe: 8 weeks

Interventionunits on scale (Mean)
Desvenlafaxine Succinate Sustained-release (DVS SR)1.93
Escitalopram1.81

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Percentage of Responders Achieving Remission at Final On-therapy Evaluation (Double Blind Continuation Phase)

Patients achieving a response to treatment at the end of the 8-week acute double blind (DB) phase continued the same treatment in a 6-month DB continuation phase and were evaluated to see if remission was achieved. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 6 months

Interventionpercentage of responders (Number)
DVS SR Responders / DVS SR DB67.9
ESC Responders / ESC DB61.3

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Percentage of Responders Improving Response to Remission During 6-month Double Blind Continuation Phase

Patients achieving a response to treatment (Responders) at the end of the 8-week acute double blind (DB) phase continued into a 6-month DB phase. Responders without remission at 8 weeks were assessed for remission status during the 6-month continuation. Remission defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale assessing 17 items characteristically associated with major depression. Individual items scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 6 months

Interventionpercentage of responders (Number)
DVS SR Responders / DVS SR DB88.9
ESC Responders / ESC DB81.8

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Percentage of Responders Maintaining Response to Treatment at Final On-therapy Evaluation (Double Blind Continuation Phase)

Patients achieving a response to treatment at the end of the 8-week acute double blind (DB) phase continued the same treatment in a 6-month DB continuation phase and were evaluated to see if the response was maintained. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 6 months

Interventionpercentage of responders (Number)
DVS SR Responders / DVS SR DB81.8
ESC Responders / ESC DB80.0

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Percentage of Patients Achieving Response to Treatment at Final On-therapy Evaluation (Acute Phase)

A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 8 weeks

Interventionpercentage of patients (Number)
Desvenlafaxine Succinate Sustained-release (DVS SR)64.3
Escitalopram73.4

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Change in Hamilton Psychiatric Rating Scale for Anxiety From Baseline to Week 8 (HAM-A) Score

The HAM-A is a standardized, clinician-administered rating scale that assesses 14 items characteristically associated with major anxiety disorders. Items are scaled 0 - 4 (0=none and 4=very severe), with a maximum total score of 56. Change= 8 week adjusted mean HAM-A total score minus baseline adjusted mean total score. (NCT00406640)
Timeframe: Baseline and Week 8

Interventionunits on scale (Mean)
Desvenlafaxine Succinate Sustained-release (DVS SR)-11.37
Escitalopram-11.73

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Change in Hamilton Psychiatric Rating Scale for Depression (HAM-D17) Score From Baseline to Week 8

HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on either a 3 point (0 to 2) or a 5 point scale (0 to 4) with 0=none/absent and 4=most severe,for a maximum total score of 50. Change= 8 week adjusted mean HAM-D17 minus baseline adjusted mean HAM-D17. (NCT00406640)
Timeframe: Baseline and 8 weeks

Interventionunits on scale (Mean)
Desvenlafaxine Succinate Sustained-release (DVS SR)-13.63
Escitalopram-14.30

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Percentage of Non-Responders Achieving Response at Final Evaluation of 6-month Open-Label (OL)Extension Phase

Patients who didn't achieve a response to treatment at the end of the 8-week acute double blind phase entered into an OL treatment phase with DVS SR for 6 months and were evaluated to see if a response was achieved. A response is defined as ≥ 50% decrease from baseline on Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 6 months

InterventionPercentage of Non-Responders (Number)
DVS SR Non-Responders / DVS SR OL39.1
ESC Non-Responders / DVS SR OL50.8

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Percentage of Non-Responders Achieving Remission at Final Evaluation of 6-month Open-Label Extension Phase

Patients who did not achieve a response to treatment at the end of the 8-week acute double blind phase entered into an open label (OL) treatment phase with DVS SR for 6 months and were evaluated to see if remission was achieved. Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 6 months

InterventionPercentage of Non-Responders (Number)
DVS SR Non-Responders / DVS SR OL40.6
ESC Non-Responders / DVS SR OL47.5

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Percentage of Patients Achieving Remission at Final On-therapy Evaluation (Acute Phase)

Remission is defined as a Hamilton Psychiatric Rating Scale for Depression (HAM-D17) score of ≤ 7. HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Individual items are scored on a 0 to 2 or 4 scale (0=none/absent and 4=most severe) for a maximum total score of 50. (NCT00406640)
Timeframe: 8 weeks

InterventionPercentage of patients (Number)
Desvenlafaxine Succinate Sustained-release (DVS SR)37.9
Escitalopram48.1

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Change in Dimension Health State EuroQol (EQ-5D) Score From Baseline to Week 8

EQ-5D is a standardized, subject-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). Change=8 week score minus baseline score. (NCT00406640)
Timeframe: Baseline and week 8

Interventionunits on scale (Mean)
Desvenlafaxine Succinate Sustained-release (DVS SR)0.25
Escitalopram0.24

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Discontinuation-Emergent Signs and Symptoms (DESS) Total Score

DESS is a clinician-administered 43-item assessment that evaluates discontinuation-emergent symptoms resulting from the withdrawal from test article. The DESS total score is the sum of the number of new symptoms and old (but worse) symptoms that appeared during tapering of the test article. A higher score indicates more symptoms. The DESS score was assessed by status of taper. (NCT00406640)
Timeframe: 6 months

,
Interventionunits on scale (Mean)
End of TherapyTaper week 1Taper week 2Post-taper
Desvenlafaxine Succinate Sustained-Release (DVS SR)1.491.182.291.61
Escitalopram (ESC)1.521.683.161.48

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Change in Clinical Global Impression Severity (CGI-S) Score From Baseline to Week

CGI-S is a global rating scale that measures the severity of a patient's disease. Using a 7-point scale, the clinician rates the severity of the patient's mental illness at the time of the assessment, relative to the clinician's experience with patients who have the same diagnosis (1= normal; 7= extremely ill). (NCT00406640)
Timeframe: Baseline and 8 weeks

Interventionunits on scale (Mean)
Desvenlafaxine Succinate Sustained-release (DVS SR)-2.09
Escitalopram-2.22

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Clinical Global Impression of Improvement Score at Week 8

The Clinical Global Impression of Improvement (CGI-I) scale measures the clinician's perception of participant improvement at the time of assessment compared with the start of treatment. Scores range from 1 (very much improved) to 7 (very much worse). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, and treatment-by-visit. (NCT00420004)
Timeframe: Week 8

Interventionunits on a scale (Least Squares Mean)
LY22166842.2
Placebo2.3
Escitalopram2.0

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Change From Baseline to Week 8 in the 21-item Hamilton Depression Rating Scale (HAM-21) Total Score

The HAMD-21 is a 21-item assessment used to measure depression severity. Items were rated on a scale from 0 (symptoms not present) to a maximum of 2 to 4 (symptom extremely severe) for a total score ranging from 0 (not at all depressed) to 60 (severely depressed). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit. (NCT00420004)
Timeframe: Baseline, Week 8

Interventionunits on a scale (Least Squares Mean)
LY2216684-13.6
Placebo-13.0
Escitalopram-15.0

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Response and Remission Rates

A participant meets response criteria if there is at least a 50% reduction in the 17-item Hamilton Depression Rating Scale (HAMD-17) total score from baseline to the last observation carried forward (LOCF) endpoint visit. A participant meets remission criteria if the HAMD-17 total score is less than or equal to 7 at the LOCF endpoint visit. The percent of participants meeting criteria is summarized. HAMD-17 is a 17-item assessment used to assess the severity of depression and its improvement during the course of therapy. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicate greater symptom severity. The total score was the sum of the scores from HAMD-17 Items 1 through 17 and ranged from 0 (not at all depressed) to 52 (severely depressed). (NCT00420004)
Timeframe: Baseline, up to Week 8

,,
Interventionpercentage of participants (Number)
ResponseRemission
Escitalopram53.742.6
LY221668454.038.7
Placebo48.431.1

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Pharmacokinetics: Predicted Maximal Concentration of LY2216684 at Steady State (Cmax,ss) at Week 8 Endpoint

Predicted maximal LY2216684 plasma concentrations at steady state (Cmax,ss) are reported, using the dose at the last visit in the study for participants included in the primary efficacy analysis. (NCT00420004)
Timeframe: Up to 8 weeks

Interventionnanograms per milliliter (ng/mL) (Mean)
3 mg dose6 mg dose9 mg dose12 mg dose
LY221668410.522.63240.6

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Change From Baseline on the 36-item Short-Form (SF-36) Health Status Survey Mental and Physical Components up to Week 8 Endpoint

The SF-36 Health Status Survey is a generic, health-related scale assessing a participant's quality of life on 8 domains: general health (GH), physical functioning (PF), role-physical, role-emotional, social functioning, bodily pain, vitality, and mental health. Each domain is scored by summing the individual items (GH [range: 5-25]; PF [range: 10-30]; role-physical [range: 4-8]; role-emotional [range: 3-6]; social functioning [range: 2-10]; bodily pain [range: 2-11]; vitality [range: 4-24]; mental health [range: 5-30]) and transforming the scores into a 0 to 100 scale, with higher scores indicating better health status or functioning. Two summary scores (mental component and physical component scores) were constructed based on the 8 SF-36 domains. Mental component summary and physical component summary scores range from 0 to 100 (higher scores indicate better health status). (NCT00420004)
Timeframe: Baseline, up to Week 8

,,
Interventionunits on a scale (Mean)
Mental Component SummaryPhysical Component Summary
Escitalopram12.42.74
LY221668413.44.17
Placebo12.62.37

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Cognitive Assessment Battery: Change From Baseline in Word List Learning and Delayed Recall Test (WLDRT) up to Week 8 Endpoint

The WLDRT is a test of visual learning and recall. Participants are shown a series of words (commonly used nouns) and asked to say each of the words aloud, then are asked to recall the words and the total number of correct words recalled is recorded (possible score ranged from 0 to 15 words). The process is repeated 3 times. The Word List Learning Test score is calculated as the average number of words recalled during the first 3 trials. After a 30-minute delay, participants are again asked to recall the words, and the total number of correct words remembered after the delay is recorded as the Delayed Recall Test score. The baseline value was the last non-missing value before the first randomized double-blind study drug administration. Least Squares (LS) means were adjusted for treatment, investigator, and baseline score. (NCT00420004)
Timeframe: Baseline, up to week 8

,,
Interventionnumber of correct words (Least Squares Mean)
Word List Learning TestDelayed Recall Test
Escitalopram0.30.0
LY22166840.50.4
Placebo0.30.2

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Number of Participants With at Least 1 Serious Adverse Event (Safety and Tolerability)

The number of participants with at least one serious adverse event, regardless of causality is reported cumulatively through Week 8. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Event module. (NCT00420004)
Timeframe: Baseline through Week 8

InterventionParticipants (Count of Participants)
LY22166842
Placebo1
Escitalopram2

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Change From Baseline to Week 8 in the 17-item Hamilton Depression Rating Scale (HAMD-17) Total Score

The HAMD-17 is a 17-item assessment used to assess the severity of depression and its improvement during the course of therapy. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicate greater symptom severity. The total score was the sum of the scores from HAMD-17 Items 1 through 17 and ranged from 0 (not at all depressed) to 52 (severely depressed). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit. (NCT00420004)
Timeframe: Baseline, Week 8

Interventionunits on a scale (Least Squares Mean)
LY2216684-13.2
Placebo-12.6
Escitalopram-14.7

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Change From Baseline in Quick Inventory of Depressive Symptomatology Total Score up to Week 8 Endpoint

The Quick Inventory of Depressive Symptomatology is a 16-item participant-rated measure of depressive symptomatology. There were 4 possible answers per question that are specific to the question; each question (Q) was scored 0 (no problems) to 3 (increased symptoms). The total score was the sum of the highest number from Q1-4, number from Q5, highest number from Q6-9, total for Q10-14, and the highest number from Q15-16. The total score ranges from 0 to 27 with higher scores indicative of greater severity of depression. Least Squares (LS) means were adjusted for treatment, investigator, and baseline score. (NCT00420004)
Timeframe: Baseline, up to Week 8

Interventionunits on a scale (Least Squares Mean)
LY2216684-10.2
Placebo-8.3
Escitalopram-11.6

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Change From Baseline in Insomnia Severity Index up to Week 8 Endpoint

The Insomnia Severity Index (ISI) is a brief self-report instrument measuring the participant's perception of his or her insomnia. The ISI score is calculated as the sum of the responses to the 7 items of the ISI scale. Each item is rated on a 0 to 4 scale and the total score ranges from 0 to 28 with a higher score suggesting more severe insomnia. (NCT00420004)
Timeframe: Baseline, up to Week 8

Interventionunits on a scale (Mean)
LY2216684-7.53
Placebo-7.44
Escitalopram-8.02

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Cognitive Assessment Battery: Change From Baseline in Symbol Digit Substitution Test (SDST) up to Week 8 Endpoint

The SDST is an attention-demanding psychomotor component based on the Digit Symbol Substitution Test from the Wechsler Adult Intelligence Scale. The participant is given a symbol/digit code in which each of the digits 1 through 9 is paired with a different symbol. Below the code, a series of symbols selected from those in the code are presented in an irregular order. The participant is instructed to write the number that is appropriate for each symbol in the space below each symbol and to complete as many correct digits as possible within a 90-second test period. For this test, the number of attempts and number of correct digits is collected. The percentage of correct digits is presented based on the number of correct digits divided by the number of attempts, multiplied by 100 (score ranged from 0 to 100% correct). Least squares (LS) means were adjusted for treatment, investigator, and baseline score. (NCT00420004)
Timeframe: Baseline, up to Week 8

Interventionpercentage of correct digits (Least Squares Mean)
LY22166843.2
Placebo2.5
Escitalopram2.2

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Cognitive Assessment Battery: Change From Baseline in Trail Making A up to Week 8 Endpoint

Trail Making A is a neurocognitive test associated with general brain function. While being timed, the participant is instructed to connect 25 randomly placed circled numbers on a page in numerical sequence without lifting their pencil. If a participant makes a mistake, the mistake is pointed out and the participant must start again from the last correct circle. The total time to complete the task (up to 300 seconds, with a lower value indicating better brain function) is recorded. Least squares (LS) means were adjusted for treatment, investigator, and baseline score. (NCT00420004)
Timeframe: Baseline, up to Week 8

Interventionseconds (Least Squares Mean)
LY2216684-9.9
Placebo-11.1
Escitalopram-5.6

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Cognitive Assessment Battery: Change From Baseline in Two Digit Cancellation Test up to Week 8 Endpoint

The Two Digit Cancellation Test (2DCT) is a clinical adaptation of the visual search tasks that have been used to investigate cognitive processes involved in attention and visual information processing. For this test, the participant is presented with a piece of paper containing rows of digits. At the top of the page are two target digits. The participant is instructed to examine each row of digits working from top to bottom and left to right crossing off each number that matches either of the two numbers at the top of the page. The number of targets hit, number of errors, and number of times the participant had to be reminded of the task are recorded for the 45-second test. The 2DCT composite cognitive score is calculated as the number of targets hit - number of errors - number of reminders. 2DCT score ranges 0-40 with higher score indicating better cognition. Least squares (LS) means were adjusted for treatment, investigator, and baseline score. (NCT00420004)
Timeframe: Baseline, up to Week 8

Interventionunits on a scale (Least Squares Mean)
LY22166840.8
Placebo1.2
Escitalopram1.0

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Change From Baseline in Arizona Sexual Experiences Scale up to Week 8 Endpoint

The Arizona Sexual Experiences Scale (ASEX) is used to assess sexual functioning in both males and females. The ASEX total score for the male and female version is calculated as the sum of the responses (rated from 1 [extremely] to 6 [no/never]) to the 5 items of the ASEX scale. Total scores ranged from 5 to 30 with higher scores indicating greater sexual dysfunction. (NCT00420004)
Timeframe: Baseline, up to Week 8

Interventionunits on a scale (Mean)
LY2216684-2.68
Placebo-1.69
Escitalopram-1.65

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Change From Baseline in Modified Overt Aggression (OAS-M) Scale up to Week 8 Endpoint

OAS-M is a clinician-administered semistructured interview designed to assess various manifestations of aggressive behavior. Final scores are rated on 3 scales: Aggression (Agg), Irritability (Irrt), Suicidality (Suic). Agg scale has 4 subscales: Verbal Assault (Aslt), Aslt Against Objects, Aslt Against Others, Aslt Against Self; each item is scored 0-5, multiplied by the frequency of the behavior, then summed together. Agg total score is the weighted sum of the subscale scores (weights: 1=Verbal Aslt, 2=Aslt Against Objects, 3=Aslt Against Others, 4=Aslt Against Self). The Irrt scale has 2 subscales: Global Irrt, Subjective Irrt. Suic scale has 3 subscales: Suicidal Tendencies, Intent of Attempt, Lethality of Attempt. The 2 Irrt and 3 Suic subscales are rated on 6 or 7 point scales from 0=none/not at all to 6/7=very extreme. The total score ranges from 0-10 for the Irrt scale and 0-16 on the Suic scale. Least Squares means were adjusted for treatment, investigator, and baseline s (NCT00420004)
Timeframe: Baseline, up to Week 8

,,
Interventionunits on a scale (Least Squares Mean)
Aggression total scoreIrritability total scoreSuicidality total score
Escitalopram-3.9-1.0-0.2
LY2216684-4.1-1.0-0.2
Placebo-4.2-0.9-0.2

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Change From Baseline in Hamilton Anxiety Rating Scale (HAMA) Total Score up to Week 8 Endpoint

The HAMA is a 14-item assessment used to assess the severity of anxiety. The investigator talked to the participant about the symptoms he or she experienced during the previous week. Each item was scored using a 5-point scale (0=not present to 4=very severe). The total score of HAMA ranged from 0 (normal) to 56 (severe). Least Squares (LS) means were adjusted for treatment, investigator, and baseline score. (NCT00420004)
Timeframe: Baseline, up to Week 8

Interventionunits on a scale (Least Squares Mean)
LY2216684-9.7
Placebo-9.6
Escitalopram-11.6

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Change From Baseline to Week 8 in Fatigue Severity Scale

"Fatigue Severity Scale (FSS) is a 9-item measure of fatigue severity. Each item is scored by the participant on a scale of 1 (Disagree) to 7 (Agree), with a higher score indicating a stronger agreement with the item statement regarding the participant's fatigue symptoms. The FSS total score ranges from 1 to 7, and is obtained by averaging the responses to the 9 items. Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit." (NCT00420004)
Timeframe: Baseline, Week 8

Interventionunits on a scale (Least Squares Mean)
LY2216684-2.0
Placebo-1.8
Escitalopram-2.2

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Change From Baseline to Week 8 in Maier-Philipp Subscale of the 17-item Hamilton Depression Rating Scale (HAMD-17)

"The HAMD-17 is a 17-item assessment used to assess the severity of depression and its improvement during the course of therapy. Each item was evaluated and scored using either a 5-point scale of 0 (not present/absent) to 4 (very severe) or a 3-point scale of 0 (not present/absent) to 2 (marked). Higher scores indicate greater symptom severity. The Maier-Phillip subscale of the HAMD-17 represents the 6 core symptoms of depression (items: 1=depressed mood, 2=feelings of guilt, 7=work and activities, 8=retardation, 9=agitation, 10=anxiety/psychic). The subscale scores range from 0 (normal) to 24 (severe). Least Squares (LS) means were calculated using mixed model repeated measures (MMRM) adjusting for treatment, investigator, visit, baseline score, treatment-by-visit, and baseline score-by-visit." (NCT00420004)
Timeframe: Baseline, Week 8

Interventionunits on a scale (Least Squares Mean)
LY2216684-6.7
Placebo-6.2
Escitalopram-7.6

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Change From Baseline in Beck Scale for Suicide Ideation up to Week 8 Endpoint

Beck Scale for Suicide Ideation (BSI) is a 21-item participant-completed questionnaire designed to assess severity of suicidal ideation in adults and adolescents. The BSI total score is calculated as the sum of the responses (rated from 0 to 2 in terms of severity) to the first 19 items of the BSI scale. The BSI total score ranges from 0 to 38, with a higher score indicating a higher degree of suicide ideation. (NCT00420004)
Timeframe: Baseline, up to Week 8

Interventionunits on a scale (Mean)
LY2216684-0.90
Placebo-0.54
Escitalopram-0.78

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Total Drinks Consumed Per Week on the TLFB

Total Drinks Consumed per Week on the Time Line Follow Back. We measure the change from Baseline to Week 12 or week of early termination visit. (NCT00452543)
Timeframe: From Baseline visit to Week 12 (or early discontinuation visit)

InterventionDrinks consumed per week (Mean)
Escitalopram Plus Acamprosate15
Escitalopram Plus Placebo15

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Total Drinking Days on the Alcohol Timeline Followback (TLFB)

The TLFB assesses recent drinking behavior. On the TLFB, clients retrospectively estimate their daily alcohol consumption in standard drinks over a time period ranging from 7 days to 24 months prior to the interview, and thus the measure provides quantitative estimates of alcohol use. One standard drink on the TLFB was defined as: 12 oz beer (5% alcohol by volume), 5 oz of wine (10-12% abv), 3 oz of fortified wine (16-18% abv), or 1-1.2 oz of hard liquor (86-100 proof; 43-50% abv). We measure the change from Baseline to Week 12 or week of early termination visit. (NCT00452543)
Timeframe: From Baseline visit to Week 12 (or early discontinuation visit)

InterventionDrinking days (Mean)
Escitalopram Plus Acamprosate61
Escitalopram Plus Placebo61

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Change in Mean Score on the Hamilton Rating Scale for Depression -- 17 Items (HAM-D-17)

Scores on the HAM-D-17 typically fall into the following ranges: a) Not depressed: 0-7; b) Mildly depressed: 7-15; c) Moderately depressed: 15-25; d) Severely depressed: over 25. A decrease of 50% or more in the Hamilton-D score is considered to be a positive response to treatment, while a score of 7 or less is considered typical of remission. We measure the change in total score from Baseline to Week 12 or week of early termination visit. (NCT00452543)
Timeframe: From baseline visit to Week 12 (or early discontinuation visit)

InterventionScores on a scale (Mean)
Escitalopram Plus Acamprosate-5.6
Escitalopram Plus Placebo-7.8

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Total Drinks Consumed Per Drinking Day on the TLFB

Total Drinks Consumed per Drinking Day on the Time Line Follow Back. We measure the change from Baseline to Week 12 or week of early termination visit. (NCT00452543)
Timeframe: From Baseline visit to Week 12 (or early discontinuation visit)

InterventionDrinks consumed per drinking day (Mean)
Escitalopram Plus Acamprosate4
Escitalopram Plus Placebo4

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Remission of Depressive Symptoms

Remission in this study is defined as both a ≥50% decrease in the 24-item Hamilton Depression Rating Scale (HDRS) Score and a final 24-item HDRS score <10. Remission of depressive symptoms was calculated for the 28 completers of the SSRI phase. (NCT00456014)
Timeframe: Measured at Week 8

Interventionparticipants (Number)
Participants achieving remissionParticipants failing to achieve remission
1 - SSRI1414

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Improvement in Scores on the Hamilton Depression Rating Scale - SSRI Phase

Mean % improvement from baseline to end of treatment trial using the 24-item Hamilton Depression Rating Scale. Percent improvement of depressive symptoms was calculated for the 28 completers of the SSRI phase. The higher the score on the 24-item HDRS, the greater the depression severity. Minimum score on the scale is 0, and maximum score is 74. Subscales are not used for this analysis. (NCT00456014)
Timeframe: Measured at Week 8

Intervention% improvement in depression symptoms (Mean)
Escitalopram ImprovementSertraline Improvement
1 - SSRI45.4630.01

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Remission of Depressive Symptoms - Tricyclic Phase

Participants who did not achieve remission during the SSRI phase advanced to the tricyclic phase of the study. Participants were treated with either desipramine or nortriptyline. Seven participants started the tricyclic phase. Four completed the tricyclic phase. The completers (n=4) were analyzed for remission status. (NCT00456014)
Timeframe: Measured over 8 weeks

Interventionparticipants (Number)
Number Achieving RemissionNumbering Failing to Remit
Tricyclic Group13

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Response and Remitter Status at Endpoint, Based on Change in Depression Severity Rating Scores

"The primary outcome in this study was based on the Hamilton Rating Scale for Depression, 17 items (HAMD-17). Clinical Response status was defined as > 50 % reduction in HAMD-17 scores from baseline to endpoint. Clinical Remitter status was defined as endpoint HAMD-17 score < 8.~40 patients (21 female) with major depressive disorder (MDD) started the 12 week study treatment with escitalopram, 25 patients (15 female) completed the 12 weeks." (NCT00464711)
Timeframe: 12 weeks

Interventionparticipants (Number)
Clinical ResponseClinical Remission
Open Label Escitalopram1614

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Percentage of Participants Who Dropped Out of Buprenorphine Treatment

Drop-out is defined as 7 or more days of missed Buprenorphine doses (NCT00475878)
Timeframe: 3 months

Interventionpercentage of participants (Number)
10 mg Escitalopram33.3
Placebo44.0

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Depressive Symptoms

Depressive symptoms, as measured by self-report during study interviews, using the Beck Depression Inventory II. Scores ranged from 0-63; higher scores indicate more depressive symptoms. (NCT00475878)
Timeframe: 3 months

Interventionunits on a scale (Mean)
10 mg Escitalopram12.31
Placebo11.35

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Time to Remission, Defined by the Week of Onset of Persistent Hamilton Rating Scale for Depression (HAM-D 17) <= 7, With no Subsequent HAM-D 17 > 7

Life Table Survival Analysis run twice, once comparing Dual Therapy (i.e., Bupropion + Escitalopram) to Bupropion alone (i.e., Bupropion + Placebo) and once comparing Dual Therapy to Escitalopram alone (i.e., Escitalopram + Placebo). Because both analyses must significantly favor Dual Therapy, each individual analysis must reach a critical alpha = .0916 in order to reach an over-all alpha = .05. (NCT00519428)
Timeframe: 12 weeks

Interventionweeks (Mean)
Escitalopram + Bupropion8
Escitalopram9
Bupropion10

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Severity of Depressive Symptoms as Measured by Hamilton Rating Scale for Depression (HAM-D 17)

"Last summary score rating on the 17-item Hamilton Rating Scale for Depression Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. Range 0-58.~0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression~≥ 23 = Very Severe Depression" (NCT00519428)
Timeframe: 12 weeks

Interventionunits on Hamilton Rating Scale for Depre (Mean)
Escitalopram + Bupropion10
Escitalopram9
Bupropion12

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Remission: Persistent Hamilton Rating Scale for Depression, 17 Items (HAM-D 17) <= 7, With no HAM-D 17 >7 Through Week 12

Chi square comparison of rates of persistent remission (i.e., no subsequent Hamilton Rating Scale for Depression, 17 items [HAMD-D 17] > 7 once HAMD-D 17 <= 7); Dual rate vs. Escitalopram only rate and Dual rate vs. Bupropion only rate. (NCT00519428)
Timeframe: 12 weeks

Interventionpercentage of participants (Number)
Escitalopram + Bupropion52
Escitalopram46
Bupropion34

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Quality of Life, as Measured by the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Short Form (SF)

"The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) intends to measure quality of life in 16 domains. A summary score is computed by adding the scores and dividing by 16 (or the number of answered items if some are not answered).~The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. Higher score means more satisfaction." (NCT00519428)
Timeframe: 12 weeks

Interventionunits on the Q-LES-Q scale (Mean)
Escitalopram + Bupropion3.0
Escitalopram3.0
Bupropion3.1

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Functioning, as Measured by the Social Adjustment Scale (SAS) Summary Score

Social adjustment was measured using the Social Adjustment Scale (SAS). The SAS is a self-report scale that assesses depressive symptoms and functioning in nine social and work-related domains generating a total score that is indicative of a subject's overall level of social adjustment. Subjects rate their own social functioning over times on a 5-point scale on items covering work for pay, housework, extended family, parenting, marital status, social activity and leisure, family unit and student status (sub-scales). Mean values of all the sub-scales are used, with a range from 0-5. Higher score = worse outcome … worse functioning (NCT00519428)
Timeframe: 12 weeks

Interventionunits on the SAS scale (Mean)
Escitalopram + Bupropion2.65
Escitalopram2.63
Bupropion2.74

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Subject Daily Symptom Rating Score.

A daily diary with 17 symptoms of PMS rated on a 5-point scale to indicate none to very severe symptoms. Minimum score 0; maximum score 408. (NCT00523705)
Timeframe: baseline and 5 months.

,
Interventionunits on a scale (Mean)
mean score at baselinemean score at endpoint (5 months)
Escitalopram155.691.6
Sugar Pill169121.3

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Depression as Assessed by the Quick Inventory of Depressive Symptomatology-Self Rated 16 (QIDS-SR-16)

Number of participants reaching pre-defined threshold on the QIDS-SR-16 of >/=11. The QIDS-SR-16 total score ranges from 0-27. Scores ranging from 0 to 10 correspond with no to mild depression, while scores >/= 11 correspond to moderate to severe depression. (NCT00536172)
Timeframe: Measured pre-treatment and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, 24, and 28

Interventionparticipants (Number)
Escitalopram6
Placebo16

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Spielberger State-Trait Anxiety Inventory Scales (STAI)

STAI measures anxiety. The questionnaire asks the patients how they feel and allows them to respond on a frequency scale that ranges from 1(not at all) to 4(almost always/very much so). Scores range from 20-80 and the higher the score the greater the anxiety level. This applies to both the Trait and State scales. End point values adjusted for baseline values age and sex. (NCT00574847)
Timeframe: 6 weeks

,
Interventionunits on a scale (Mean)
TraitState
Escitalopram31.227.9
Placebo32.029.5

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5HTT, Serotonin Transporter Protein

End point values adjusted for baseline values age and sex. (NCT00574847)
Timeframe: week 6

Interventionfmol/mg (Mean)
Escitalopram139.7
Placebo160.4

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Beck Depression Inventory

The Beck Depression Inventory II (BDI-II) is a 21 question, self-administered measure of depressive symptoms. Score range, 0 to 63 (higher score=greater severity of depressive symptoms). End point values adjusted for baseline values age and sex. (NCT00574847)
Timeframe: 6 week

Interventionunits on a scale (Mean)
Escitalopram7.4
Placebo7.0

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Cook-Medley Hostility (Ho) Hostile Affect Sub-scale

hostile affect, 0 to 5 (higher score=greater levels of hostile affect). End point values adjusted for baseline values age and sex. (NCT00574847)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Escitalopram1.6
Placebo1.8

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Cook-Medley Hostility (Ho) Scale

Score ranges: hostility, 0 to 27 (higher score=greater levels of hostility)/ End point values adjusted for baseline values age and sex. (NCT00574847)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Escitalopram9.9
Placebo10.3

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Exercise Stressed-induced Myocardial Ischemia (ESIMI)

End point values adjusted for baseline values age and sex. (NCT00574847)
Timeframe: 6 week

Interventionpercentage of change (Number)
Escitalopram45.8
Placebo52.5

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Mental Stress Induced Change in Heart Rate

"A standard 12-lead Electrocardiograph (ECG) will be recorded at 1-minute intervals during the last 3 minutes of each rest period, the 3 minutes of the mental stress testing, and during exercise testing. Heart rate will be determined from the ECGs.~Mental Stress Induced Change in heart rate will be calculated by taking the mean of the mental stress heart rate measurements minus the resting heart rate measurements. End point values adjusted for baseline values age and sex." (NCT00574847)
Timeframe: baseline, 6 weeks

Interventionbeats/minute (Mean)
Escitalopram6.34
Placebo9.1

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Mental Stress Induced Change of Diastolic Blood Pressure

Blood pressure will be measured the last 3 minutes of the 20 minute calibration period (resting), every minute during the 3 minutes mental stress testing, the last 3 minutes of the 6 minute rest periods between mental stress testing, and every minute during and after the physical stress testing with an automatic oscillometric blood pressure monitor (Quinton Electronics). Mental Stress Induced Change of Diastolic Blood Pressure will be calculated by taking the mean of the mental stress Diastolic blood pressure measurements minus the resting Diastolic blood pressure. End point values adjusted for baseline values age and sex. (NCT00574847)
Timeframe: Baseline, week 6

Interventionmm Hg (Mean)
Escitalopram11.4
Placebo12.2

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Mental Stress Induced Change of Systolic Blood Pressure

Blood pressure will be measured the last 3 minutes of the 20 minute calibration period (resting), every minute during the 3 minutes mental stress testing, the last 3 minutes of the 6 minute rest periods between mental stress testing, and every minute during and after the physical stress testing with an automatic oscillometric blood pressure monitor (Quinton Electronics). Mental Stress Induced Change of Systolic Blood Pressure will be calculated by taking the mean of the mental stress systolic blood pressure measurements minus the resting Systolic blood pressure. End point values adjusted for baseline values age and sex. (NCT00574847)
Timeframe: Baseline, week 6

Interventionmm Hg (Mean)
Escitalopram19.3
Placebo23.6

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Perceived Stress Scale

Score range, 10 to 50 (higher score = greater levels of perceived stress). End point values adjusted for baseline values age and sex. (NCT00574847)
Timeframe: 6 weeks

Interventionunits on a scale (Mean)
Escitalopram21.4
Placebo21.8

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Percentage of Participants With Adverse Events

(NCT00574847)
Timeframe: Baseline to week 6

Interventionpercentage of participants (Number)
Escitalopram71.9
Placebo44.4

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Percentage of Participants With an Absence of Mental Stress-induced Myocardial Ischemia (MSIMI) During the 3 Mental Stressors

MSIMI is defined by the following: compared to rest, 1) any development of new abnormal wall motion; 2) reduction of LVEF 8% and/or; 3) deviation (depression or elevation) of ST-segment of ECG in 2 or more leads lasting for 3 consecutive beats, occurring during at least one of the 3 mental stress tasks. (NCT00574847)
Timeframe: Week 6

Interventionpercentage of participants (Number)
Escitalopram34.2
Placebo17.5

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Percentage of Participants With Overall Mental Stress-induced Myocardial Ischemia (MSIMI)

MSIMI is defined by the following: compared to rest, 1) any development of new abnormal wall motion; 2) reduction of LVEF 8% and/or; 3) deviation (depression or elevation) of ST-segment of ECG in 2 or more leads lasting for 3 consecutive beats, occurring during at least one of the 3 mental stress tasks. (NCT00574847)
Timeframe: week 6

Interventionpercentage of participants (Number)
Escitalopram66.1
Placebo83.9

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Platelet Serotonin Binding Affinity Kd_100

End point values adjusted for baseline values age and sex. (NCT00574847)
Timeframe: 6 weeks

InterventionnM (Mean)
Escitalopram4202.4
Placebo210.1

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Quality of Life Inventory

The Quality of Life Inventory (QOLI) is a 32-item comprehensive self-report of satisfaction in 16 areas of life, such as love, work, and health. Each area is rated in terms of satisfaction and the relationship of that area to overall quality of life. It yields an overall raw score and satisfaction ratings for the 16 individual areas of life. The QOLI raw score is an average of weighted satisfaction ratings computed only over areas of life judged to be Important or Extremely Important to the respondent. Higher scores indicate higher reported quality of life. (NCT00590863)
Timeframe: Measured at Month 7

Interventionunits on a scale (Mean)
Escitalopram + Bupropion SR0.6
Venlafaxine XR + Mirtazapine0.4
Escitalopram + Placebo0.4

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Quick Inventory of Depressive Symptoms

Percentage of patients that achieve remission, as defined as QIDS total score below 6 for last 2 study visits. QIDS depression scores range from 0 (normal) to 27 (very severe). (NCT00590863)
Timeframe: Measured at Month 7

Interventionpercentage of participants (Number)
Escitalopram + Bupropion SR46.6
Venlafaxine XR + Mirtazapine41.8
Escitalopram + Placebo46.0

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Hamilton Anxiety Rating Scale

The Hamilton Anxiety Rating Scale is a clinician-rated measure of cognitive and somatic anxiety symptoms. It consists of 14 items, each of which is scored on a 0-4 scale, summed for a total score ranging from 0 to 56. Inclusion criteria for this study included a Hamilton score >= 17. The Hamilton, administered by blind raters, will be used to test hypotheses number 1 and 2. The outcome of interest is the number of participants who relapse, defined as having a Hamilton increase of >=5, for a total Hamilton >=14, relative to the end of the continuation phase (week 28), for a duration of at least 2 weeks, plus both clinician's and participant's judgment that the participant is experiencing a recurrence of anxiety symptoms. HAMA scores range from 0 (no anxiety) to 56 (high anxiety). (NCT00601965)
Timeframe: 56 weeks

Interventionparticipants (Number)
Escitalopram + CBT18
Escitalopram + no CBT15
Placebo + CBT14
Placebo + no CBT8

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Penn State Worry Questionnaire

The Penn State Worry Questionnaire is a 16-item measure of pathological worry. Scores range from 16-80, with higher scores indicating higher levels of worry. (NCT00601965)
Timeframe: 56 weeks

Interventionunits on a scale (Mean)
Escitalopram + CBT52.8
Escitalopram + no CBT53.4
Placebo + CBT54.4
Placebo + no CBT57.7

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IDS-SR (Inventory of Depressive Symptomatology - Self-Report)

The IDS-SR is a 30 item (self-report questionnaire) designed to assess symptoms of depression. Scores range from 0 to 90. The higher the score, the worse the depressive symptoms (worse outcome). (NCT00621946)
Timeframe: Up to 12 weeks

Interventionunits on a scale (Mean)
Escitalopram26.3
Matching Placebo24.6

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IDS-SR (Inventory of Depressive Symptomatology - Self-Report)

The IDS-SR is a 30 item (self-report questionnaire) designed to assess symptoms of depression. Scores range from 0 to 90. The higher the score, the worse the depressive symptoms (worse outcome). (NCT00621946)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Escitalopram35.2
Placebo42.9

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ACQ (Asthma Control Questionnaire)

The ACQ is a questionnaire used to assess symptoms pertinent to asthma management. Scores range from 0 to 42. The higher the score, the worse the asthma symptoms (worse outcome). The total ACQ score is obtained by dividing the raw score by the total number of items (in this case 7 items). (NCT00621946)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Escitalopram1.9
Placebo2.9

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ACQ (Asthma Control Questionnaire)

The ACQ is a questionnaire used to assess symptoms pertinent to asthma management.Scores range from 0 to 42. The higher the score, the worse the asthma symptoms (worse outcome). The total ACQ score is obtained by dividing the raw score by the total number of items (in this case 7 items). (NCT00621946)
Timeframe: Up to 12 weeks

Interventionunits on a scale (Mean)
Escitalopram1.9
Matching Placebo2.4

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HAM-D (Hamilton Rating Scale for Depression)

The HAM-D is a 17 item questionnaire (a clinician-administered depression scale) designed to evaluate severity of depressive symptoms. Scores can range from 0 to 52. The higher the score, the worse the depressive symptoms (worse outcome). (NCT00621946)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Escitalopram24.8
Placebo28.3

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HAM-D (Hamilton Rating Scale for Depression)

The HAM-D is a 17 item questionnaire (a clinician-administered depression scale) designed to evaluate severity of depressive symptoms. Scores can range from 0 to 52. The higher the score, the worse the depressive symptoms (worse outcome). (NCT00621946)
Timeframe: Up to 12 weeks

Interventionunits on a scale (Mean)
Escitalopram16.7
Matching Placebo17.7

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Change in Weight

(NCT00636649)
Timeframe: Baseline, 12 week

Interventionkg (Mean)
Escitalopram-0.43
Placebo1.12

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Night Eating Questionnaire

The Night Eating Questionnaire (NEQ) is a 14-item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hyperphagia, morning anorexia, and mood/sleep. Scores range from 0-56, with higher scores indicative of greater severity. The NEQ has an acceptable internal consistency reliability (.70). A cut-score of 25 has been shown to yield a positive predictive value of .62. (NCT00636649)
Timeframe: baseline, 12 weeks

Interventionunits on a scale (Mean)
Escitalopram-13.0
Placebo-10.6

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Number of Participants Who Had a 50% Reduction in NEQ Scores

The Night Eating Questionnaire (NEQ) is a 14 item self-report scale designed to assess the symptoms of NES including nocturnal ingestions, evening hypcrphagia, morning anorexia, and mood/slccp. Scores range from 0 to 56, with higher scores indicative of greater severity. (NCT00636649)
Timeframe: Week 12

Interventionparticipants (Number)
Escitalopram7
Placebo6

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Number of Participants With a Clinical Global Impression - Improvement (CGI-I) Score ≤ 2

The CGI-I scale is a clinician rating of overall therapeutic effect ranging from 1 (very much improved) to 7 (very much worse) since commencing treatment. (NCT00636649)
Timeframe: 12 weeks

Interventionparticipants (Number)
Escitalopram12
Placebo7

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Change in Coping Inventory for Stressful Situations (CISS)

TASK = task-oriented coping; EMOT = emotion-oriented coping; AVD = avoidance-focused coping; Avoidance-focused coping may be divided into two subtypes: DIS = distraction-oriented coping; SOC = social diversion-oriented coping. CISS is a 48 item self-report measure used to measure responses to stressful situations rated for frequency on a 5 point Likert scales ranging from1, not at all to 5, very much. This measure assesses three coping styles: Task-Oriented, Emotion-Oriented, and two types of Avoidance-Oriented coping (Social Diversion and Distraction). There are 16 items on each of the primary scales (task, emotion, avoidance) and 5 on social diversion and 8 on distraction. Scores are summed for each subscale and then converted to gender-corrected t-scores with a mean of 50 and a standard deviation of 10. T-scores on the CISS range from a low of 25 (1st percentile) to 75 (99th percentile). Higher scores indicate more adaptive levels of coping. (NCT00636649)
Timeframe: Baseline, 12 weeks

,
Interventiont-scores (Mean)
CISS-TASKCISS-EMOTCISS-AVDCISS-DISCISS-SOC
Escitalopram1.75-1.452.601.952.15
Placebo2.351.2503.40-2.45

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Change in Lipid Panel

(NCT00636649)
Timeframe: Baseline,12 weeks

,
Interventionmg/dL (Mean)
HDLLDLTriglyceridestotal cholesterol
Escitalopram-2.8-3.927.5-4.5
Placebo-2.22.8-14.0-2.3

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Change in Three Factor Eating Questionnaire (TFEQ)

"The TFEQ (also known as the Eating Inventory) measures dimensions of eating behavior including cognitive restraint of eating, disinhibition, and hunger using a combination of dichotomous questions, 4-point likert scales, and one 5-point likert scale. Restraint is comprised of the responses to 21 questions with possible scores ranging from 0 to 21 (Low scores for all scales indicate an uninhibited eating behavior.). Disinhibition is comprised of the responses to 16 questions with possible scores ranging from 0 to 16 (High scores indicate an uninhibited eating behavior strongly depending on external cues). Hunger is comprised of the responses to 14 questions with possible scores ranging from 0 to 14 ( Low scores indicate an eating behavior strongly depending on feelings of hunger.).~RES = Restraint Subscale; DIS = Disinhibition Subscale; HUN = Hunger Subscale" (NCT00636649)
Timeframe: Baseline, 12 weeks

,
Interventionunits on a scale (Mean)
TFEQ-RESTFEQ-DISTFEQ-HUN
Escitalopram1.85-1.50-1.75
Placebo2.95-0.85-1.60

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Change in Beck Anxiety Inventory (BAI) Score

The Beck Anxiety Inventory (BAI) is a 21-item self-report measure of anxiety. Scores range from 0 to 63, with higher scores indicative of higher levels of anxiety. (NCT00636649)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Mean)
Escitalopram-1.5
Placebo-1.8

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Change in Beck Depression Inventory II (BDI-II) Score

The BDI-II is a 21-item self-report questionnaire designed to measure cognitive, somatic, and behavioral aspects of depression. Scores range from 0 to 63, with higher scores indicating a higher level of depressive symptoms. (NCT00636649)
Timeframe: Baseline, 12 weeks

Interventionunits on a scale (Mean)
Escitalopram-2.4
Placebo-3.5

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Change in Glucose

(NCT00636649)
Timeframe: Baseline, 12 Week

Interventionmg/dL (Mean)
Escitalopram3.9
Placebo7.6

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Change in Perceived Stress Scale (PSS)

The Perceived Stress Scale (PSS) measures the overall level of stress. This instrument contains 14 items accessing overall appraisals of stress in the past month. Minimum score (best value)=0. Maximum score (worst value)=56. A higher score indicates greater stress. (NCT00636649)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Placebo-0.55
Escitalopram-2.11

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Number of Participants Who no Longer Meet the NESHI Criteria

The Night Eating Syndrome History and Inventory (NESHI) is an unpublished, semistructured interview used to confirm a diagnosis of NES. It assesses a typical 24-hour food intake, including a recall of all meals and snacks, and sleeping patterns. Based on the recall of all meals and snacks, the interviewer judged whether ≥25% of the daily caloric intake was eaten after the evening meal and how often nocturnal ingestions occurred. The NEQ items were reviewed and informed by the dietary recall during the interview, and a new total score was tallied. A final score of ≥25 for the NEQ items, as reviewed during the NESHI, was used as the criterion for NES. (NCT00636649)
Timeframe: Week 12

Interventionparticipants (Number)
Escitalopram16
Placebo12

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Social Adjustment Scale - Self-Report (SAS-SR)

The Social Adjustment Scale - Self-Report (SAS-SR) is a 54-item self-report measure of instrumental and expressive role performance. Each item is rated on a 5-point scale, and a mean item score (ranging from 1-5) is obtained, with higher scores indicating greater impairment. (NCT00642694)
Timeframe: 12 Weeks

Interventionmean score on a scale (Mean)
Escitalopram + Ramelteon2.09
Escitalopram + Placebo2.03

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Hamilton Rating Scale for Depression 17-item

The Hamilton Rating Scale for Depression is a clinician-administered rating scale that assesses severity of depressive symptoms and is one of the most widely used and validated symptom severity measures for depression. Each of the 17 items is rated by the clinician on either a 3- or a 5 point scale. Total scores range from 0-52, with higher scores indicating greater depressive symptoms. (NCT00642694)
Timeframe: 12 Weeks

Interventionscore on a scale (Mean)
Escitalopram + Ramelteon8.33
Escitalopram + Placebo10.08

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Work and Social Adjustment Scale (WSAS)

The Work and Social Adjustment Scale (WSAS) is 5-item self-report measure designed to identify functional impairment that is attributed to an identified problem or condition. and has been used in studies of depression and anxiety. Scores range between 0-40, with higher scores indicating worse functioning. (NCT00642694)
Timeframe: 12 Weeks

Interventionscore on a scale (Mean)
Escitalopram + Ramelteon15.56
Escitalopram + Placebo13.91

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Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) measures satisfaction and enjoyment in various domains of functioning: physical health, feelings, work, household duties, school/course work, leisure time activities, social relations, and general activities. The raw score is converted into a percent of the maximum possible score and ranges from 0 to 100. Higher scores indicate greater enjoyment and satisfaction. (NCT00642694)
Timeframe: 12 Weeks

Interventionscore on a scale (Mean)
Escitalopram + Ramelteon69.84
Escitalopram + Placebo70.24

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Short-Form Health Survey - Version 2 (SF-36)

The Short-Form Health Survey - version 2 (SF-36) is a self-report inventory measuring different domains of health-related quality of life: Physical Functioning, Physical Role Functioning, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Functioning, and Mental Health. Scores range from 0 to 100, with higher scores indicating better perceived health and functioning. (NCT00642694)
Timeframe: 12 Weeks

,
Interventionscore on a scale (Mean)
Physical FunctioningSocial FunctioningPhysical Role FunctioningEmotional Role FunctioningMental HealthVitalityBodily PainGeneral Health
Escitalopram + Placebo88.3368.7586.1175.0070.4254.6987.9679.25
Escitalopram + Ramelteon80.5069.4475.0067.5968.0049.3875.3174.90

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Sleep Latency

Number of minutes until fell asleep (NCT00642694)
Timeframe: 12 weeks

Interventionminutes (Mean)
Escitalopram + Ramelteon30.4
Escitalopram + Placebo15.8

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Patient Perception of Benefits of Care (PPBC)

The Patient Perception of Benefits of Care (PPBC) assesses how much patients believe their quality of life will improve in response to medical care or treatment. Scores range between 10-50, with lower scores indicating greater belief that treatment will improve quality of life. (NCT00642694)
Timeframe: 12 Weeks

Interventionscore on a scale (Mean)
Escitalopram + Ramelteon20.33
Escitalopram + Placebo20.08

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Percentage of Remitters on IDS-C30 at Week 12

Remission as defined by a score of <12 on the Inventory of Depressive Symptomatology, Clinician-Rated version (IDS-C30) at Week 12; minimum possible score = 0, maximum possible score = 84; higher scores indicate worse symptom severity (NCT00642694)
Timeframe: 12 Weeks

Interventionpercentage of participants (Number)
Escitalopram + Ramelteon20
Escitalopram + Placebo36

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Work Productivity and Activity Impairment Questionnaire (WPAI)

The Work Productivity and Activity Impairment Questionnaire (WPAI) was used to report impairment while working or performing usual daily activities as a result of health problems. The activity impairment item (#6 of WPAI) is rated on a scale of 0-10, with higher scores indicating greater impairment. Scores are multiplied by 10 to obtain percent impairment. (NCT00642694)
Timeframe: 12 Weeks

Interventionpercentage of time activity was impaired (Mean)
Escitalopram + Ramelteon40.00
Escitalopram + Placebo32.50

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Change in Hamilton Depression Scale (HAM-D) Score

The Hamilton Depression Rating Scale (HAM-D) is a clinician-administered tool used to determine a patient's level of depression before, during, and after treatment. The HAM-D form lists 21 items, but the scoring is based on the first 17 questions. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2. The scores from each item are added together to provide a total score. The sum of the scores from the first 17 questions provides an indication for level of depression. 0-7 = normal, 8-13 = mild depression, 14-18 = moderate depression, 19-22=severe depression and ≥ 23=very severe depression. (NCT00643162)
Timeframe: 9 weeks

Interventionunits on a scale (Mean)
Swedish Massage13
Light-Touch10.7

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Change in Hamilton Anxiety Scale (HAM-A) Score

The Hamilton Depression Rating Scale (HAM-D) is a clinician-administered tool used to determine a patient's level of anxiety before, during, and after treatment. The HAM-A is a 14-item assessment and each item is scored on a 5-point scale, ranging from 0 = not present to 4 = very severe. The sum of the scores is: 0-17 = mild anxiety, 18-24 = moderate anxiety, 25-30 = severe anxiety, and >30 = very severe anxiety. (NCT00643162)
Timeframe: 9 weeks

Interventionunits on a scale (Mean)
Swedish Massage5.3
Light-Touch2.7

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Change in Beck Depression Inventory Score

The Beck Depression Inventory (BDI) is a series of 21-question, self-report rating inventory developed at a 5th grade reading level that measures characteristic attitudes and symptoms of depression. It was develop to detect, assess and monitor changes in depressive symptoms. For people who have been clinically diagnosed with depression, scores from 0 to 9 represent minimal depressive symptoms, scores of 10 to 16 indicate mild depression, scores of 17 to 29 indicate moderate depression, and scores of 30 to 63 indicate severe depression. (NCT00643162)
Timeframe: 9 weeks

Interventionunits on a scale (Mean)
Swedish Massage8.7
Light-Touch6.3

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Change From Baseline in Hamiltion Rating Scale for Depression (HAM-D) at Week 8

The HAMD is a clinician-rated 24-item scale was used to rate the patient's depressive state. It was also used to identify obsessive-compulsive, genital, and somatic symptoms, as well as diurnal variation in the presence of symptoms. Each item was scored on a 3, 4 or 5-point Likert scale. A score of 0 indicated the absence of symptoms, and a score of 2, 3 or 4 indicated symptoms of maximum severity. The total score range is 0 to 74 (higher score indicates a greater depressive state). (NCT00668525)
Timeframe: Change from baseline in HAM-D at week 8

InterventionUnits on a scale (Mean)
Escitalopram Low Dose-11.5
Escitalopram High Dose-11.6
Placebo-8.5

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Change From Baseline in Total Montgomery Asberg Depression Rating Scale (MADRS) at 8 Weeks.

The MADRS is a 10-item clinician-rated scale that was used to assess depressive symptomatology over the patient's prior week. Patients were rated on 10 items designed to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item was scored on a 7-point Likert scale; a score of 0 indicated the absence of symptoms, and a score of 6 indicated symptoms of maximum severity. The total score range is 0 to 60 (higher score indicates a greater severity of symptoms). (NCT00668525)
Timeframe: Change from baseline in MADRS total score at week 8

InterventionUnits on a scale (Mean)
Escitalopram Low Dose-12.8
Escitalopram High Dose-13.4
Placebo-10.1

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% Change of Whole Brain Volume

(NCT00702780)
Timeframe: 52 weeks

Interventionpercentage of change (Mean)
Escitalopram-3.27
Placebo-2.30

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% Change of Hippocampus Volume

(NCT00702780)
Timeframe: 52 weeks

Interventionpercentage of change (Mean)
Escitalopram-7.63
Placebo-7.28

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17-item Hamilton Depression Rating Scale (HAM-D)

Standard scale for depression used in clinical trials. Range: 0 - 54. A score of 0-7 is considered to be normal. 8 - 13 mild depression. Scores of 20 or higher indicate moderate -severe depression. (NCT00707863)
Timeframe: Baseline and 8 weeks

,
Interventionunits on a scale (Mean)
Baseline 17-item HAM-DPost-8 week treatment 17-item HAM-D
Depressed Subjects Age: 16 - 50 Yrs196
Depressed Subjects Age: 18 - 25 Yrs186

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Cocaine Positive Urines

Number of urine drug screens positive for cocaine metabolite benzoylecgonine. (NCT00732901)
Timeframe: 5 weeks of treatment

InterventionPositive urine drug screens (Number)
A (Escitalopram)9
B (Placebo)8

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Attentional Bias as Measured by the Cocaine Stroop Task.

Attentional bias is the difference in reaction time to cocaine related words and neutral words. A slower reaction time indicates greater attentional bias. (NCT00732901)
Timeframe: 5 weeks of treatment

,
Interventionmilliseconds (Mean)
BaselineAcuteChronic Day 1Chronic Day 2Chronic Day 3Chronic Day 4
A (Escitalopram)90.2-8.656.445.023.463.6
B (Placebo)45.937.435.415.4-11.34.4

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Activations in Different Cortical Regions Caused by Emotionally Evocative Task

MRI scans from 41 participants (23 depressed and 18 controls), including fMRI scans using an emotional distractor task, were analyzed for differences between groups in activation in a priori regions (amygdala and DLPFC), measured with BOLD signal, for two conditions of the task - attend fearful and ignore fearful, both at baseline and following 8 weeks of treatment for the depressed group. Voxel-wise comparisons (ANOVAs) were performed to determine differences in activations between groups within these regions. Positive values reflect a BOLD activation in that region; negative reflects a BOLD de-activation in that region. We expect more positive values (greater activation) in depressed participants at baseline than in controls during the attend fearful task, and more negative values (greater de-activation) in controls at baseline than depressed during the ignore fearful task. These differences were expected to lessen significantly following treatment in the depressed group. (NCT00749125)
Timeframe: baseline and week 8

,
InterventionVoxels (Mean)
Baseline - Amygdala - attend fearBaseline - Amygdala - ignore fearBaseline - DLPFC - attend fearBaseline - DLPFC - ignore fearTime 2 - Amygdala - attend fearfulTime 2 - Amygdala - Ignore fearfulTime 2 - DLPFC - Attend fearfulTime 2 - DLPFC - Ignore fearful
1 Lexapro-0.0210.0210.0720.063-0.031-0.0310.0260.091
2 Control0.084-0.030-0.0250.073-0.032-0.0410.0750.109

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Montgomery Asberg Depression Rating Scale (Depression Severity)

A published and widely used scale for measuring severity of depression. Montgomery Asberg Depression Rating Scale scores can range from 0-60. Higher scores indicate greater severity of depression. Total scores are reported with no subscales. (NCT00754936)
Timeframe: 14 weeks from enrollment (12 weeks from medication start)

Interventionunits on a scale (Mean)
Escitalopram12.23

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Hamilton Depression Rating Scale (Depression Severity)

A published and widely-used scale for rating depression severity, the Hamilton Depression Rating Scale 24 item total scores range from 0-76. Higher scores indicate greater severity of depression. Total scores are reported with no subscales. (NCT00754936)
Timeframe: 14 weeks from enrollment (12 weeks from medication start)

Interventionunits on a scale (Mean)
Escitalopram11.47

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Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 16 Score (Overall Life Satisfaction).

The Q-LES-Q (Short Form) is a self-report measure designed to enable physicians to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. According to the scoring system suggested for this questionnaire, item 16 (Overall Life Satisfaction) will yield a separate subscore. (NCT00797966)
Timeframe: Week 8 to Week 14

InterventionUnits on a scale (Mean)
OPC-34712 0.15 mg Fixed Dose0.30
OPC-34712 0.5 ± 0.25 mg Low Dose0.30
OPC-34712 1.5 ± 0.5 mg High Dose0.35
Placebo0.28

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Change From the End of Phase A (Week 8 Visit) to the End of Phase B (Week 14 Visit) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score.

"The MADRS is utilized as the primary efficacy assessment of a participant's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place." (NCT00797966)
Timeframe: Week 8 to Week 14

InterventionUnits on a scale (Least Squares Mean)
OPC-34712 0.15 mg Fixed Dose-6.62
OPC-34712 0.5 ± 0.25 mg Low Dose-6.46
OPC-34712 1.5 ± 0.5 mg High Dose-8.23
Placebo-6.09

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Percentage of Participants With CGI-I Response From End of Phase A (Week 8 Visit).

CGI-I response is defined as CGI-I of 1 [very much improved] or 2 [much improved]. (NCT00797966)
Timeframe: Week 9, 10, 11, 12, 13 and 14.

,,,
Interventionpercentage of participants (Number)
Week 9 (N=62, 117, 116, 121)Week 10 (N=62, 119, 118, 126)Week 11 (N=62, 119, 118, 126)Week 12 (N=62, 119, 118, 126)Week 13 (N=62, 119, 118, 126)Week 14 (N=62, 119, 118, 126)
OPC-34712 0.15 mg Fixed Dose16.125.832.335.537.138.7
OPC-34712 0.5 ± 0.25 mg Low Dose11.117.629.433.637.037.0
OPC-34712 1.5 ± 0.5 mg High Dose14.724.635.642.449.252.5
Placebo14.927.029.431.733.341.3

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Percentage of Participants With MADRS Remission From End of Phase A (Week 8 Visit).

A MADRS remission was defined as MADRS Total Score /= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit). (NCT00797966)
Timeframe: Week 8 to each of Week 9, 10, 11, 12, 13 and 14.

,,,
InterventionPercentage of participants (Number)
Week 9 (N=61, 117, 116, 121)Week 10 (N=62, 119, 118, 126)Week 11 (N=62, 119, 118, 126)Week 12 (N=62, 119, 118, 126)Week 13 (N=62, 119, 118, 126)Week 14 (N=62, 119, 118, 126)
OPC-34712 0.15 mg Fixed Dose3.288.0612.921.019.422.6
OPC-34712 0.5 ± 0.25 mg Low Dose1.715.0410.110.116.815.1
OPC-34712 1.5 ± 0.5 mg High Dose1.7210.214.419.515.323.7
Placebo4.138.7311.110.315.113.5

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Percentage of Participants With MADRS Response From End of Phase A (Week 8 Visit).

A MADRS response was defined as >/= 50% reduction in MADRS Total Score from end of Phase A (Week 8 visit). (NCT00797966)
Timeframe: Week 8 to each of Week 9, 10, 11, 12, 13 and 14.

,,,
InterventionPercentage of participants (Number)
Week 9 (N=61, 117, 116, 121)Week 10 (N=62, 119, 118, 126)Week 11 (N=62, 119, 118, 126)Week 12 (N=62, 119, 118, 126)Week 13 (N=62, 119, 118, 126)Week 14 (N=62, 119, 118, 126)
OPC-34712 0.15 mg Fixed Dose4.928.0619.430.624.227.4
OPC-34712 0.5 ± 0.25 mg Low Dose6.848.4015.115.122.720.2
OPC-34712 1.5 ± 0.5 mg High Dose2.5911.018.625.425.434.7
Placebo8.269.5213.511.918.319.8

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Clinical Global Impression-Improvement Scale (CGI-I) Score at Each Study Week Visit in Phase B.

CGI-I items are: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) will be set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI-I was assessed at each visit in Phase B, and improvement is judged with respect to the participant's condition at baseline. CGI-I was also assessed at each visit in Phase B, but in that phase improvement is judged with respect to the partcipant's condition at the end of Phase A. (NCT00797966)
Timeframe: Week 8 to each of Week 9, 10, 11, 12, 13 and 14.

,,,
InterventionUnits on a scale (Mean)
Week 9 (N=62, 117, 116, 121)Week 10 (N=62, 119, 118, 126)Week 11 (N=62, 119, 118, 126)Week 12 (N=62, 119, 118, 126)Week 13 (N=62, 119, 118, 126)Week 14 (N=62, 119, 118, 126)
OPC-34712 0.15 mg Fixed Dose3.393.162.942.872.852.74
OPC-34712 0.5 ± 0.25 mg Low Dose3.303.193.022.902.762.78
OPC-34712 1.5 ± 0.5 mg High Dose3.202.952.802.702.642.52
Placebo3.313.112.942.952.902.83

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Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Clinical Global Impression - Severity of Illness Scale (CGI-S) Score.

CGI-S items are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale from 1 through 7. CGI-S was assessed at screening, baseline and each subsequent visit from Week 1 through Week 14. (NCT00797966)
Timeframe: Week 8 to Week 14

InterventionUnits on a scale (Least Squares Mean)
OPC-34712 0.15 mg Fixed Dose-0.83
OPC-34712 0.5 ± 0.25 mg Low Dose-0.81
OPC-34712 1.5 ± 0.5 mg High Dose-1.06
Placebo-0.71

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Change From End of Phase A (Week 8 Visit) in Mean CGI-S Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.

CGI-S items are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill patients. The score 0 (= not assessed) was set to missing. The CGI-S was therefore a 7-point scale from 1 through 7. CGI-S was assessed at screening, baseline and each subsequent visit from Week 1 through Week 14. (NCT00797966)
Timeframe: Week 8 to each of Week 9, 10, 11, 12 and 13.

,,,
InterventionUnits on a scale (Mean)
Week 9 (N=62,117,116,121)Week 10 (N=62,119,118,126)Week 11 (N=62,119,118,126)Week 12 (N=62,119,118,126)Week 13 (N=62,119,118,126)
OPC-34712 0.15 mg Fixed Dose-0.21-0.42-0.53-0.76-0.74
OPC-34712 0.5 ± 0.25 mg Low Dose-0.26-0.39-0.53-0.66-0.78
OPC-34712 1.5 ± 0.5 mg High Dose-0.33-0.61-0.69-0.86-0.88
Placebo-0.21-0.40-0.47-0.52-0.59

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Change From End of Phase A (Week 8 Visit) in MADRS Total Score for Every Study Week Visit in Phase B Other Than the Week 14 Visit.

"The MADRS is utilized as the primary efficacy assessment of a patient's level of depression. The MADRS consists of 10 items, all rated on a 0 to 6 scale with 0 being the best rating and 6 being the worst rating. The MADRS Total Score is the sum of ratings for all 10 items. The possible Total scores are from 0 to 60. The MADRS Total Score was unevaluable if less than 8 of the 10 items are recorded. If 8 or 9 of the 10 items were recorded, the MADRS Total Score was the mean of the recorded items multiplied by 10 and then rounded to the first decimal place." (NCT00797966)
Timeframe: Week 8 to each of Week 9, 10, 11, 12 and 13.

,,,
InterventionUnits on a scale (Mean)
Week 9 (N=61,117,116,121)Week 10 (N=62,119,118,126)Week 11 (N=62,119,118,126)Week 12 (N=62,119,118,126)Week 13 (N=62,119,118,126)
OPC-34712 0.15 mg Fixed Dose-2.13-3.69-5.53-6.97-6.90
OPC-34712 0.5 ± 0.25 mg Low Dose-3.00-3.78-5.71-6.31-6.76
OPC-34712 1.5 ± 0.5 mg High Dose-2.75-4.97-5.88-7.01-7.18
Placebo-2.48-3.64-4.40-4.41-5.47

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Change From End of Phase A (Week 8 Visit) for Every Study Week Visit in Phase B in Inventory of Depressive Symptomatology (Self-Report) (IDS-SR) Total Score.

"The IDS-SR is a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of major depressive disorders. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the best rating and 3 being the worst rating. The IDS-SR Total Score is the sum of ratings of 28 item scores. The possible IDS-SR Total Score ranges from 0 to 84. The IDS-SR Total Score was un-evaluable if less than 23 of the 28 items are recorded. If the number of items was at least 23 and at most 27, the IDS-SR Total Score will be the mean of the recorded items multiplied by 28 and then rounded to the first decimal place." (NCT00797966)
Timeframe: Week 8 to each of Week 9, 10, 11, 12, 13 and 14

,,,
InterventionUnits on a scale (Mean)
Week 9 (N=61, 117,116,121)Week 10 (N=62, 119, 118, 126)Week 11 (N=62, 119, 118, 126)Week 12 (N=62, 119, 118, 126)Week 13 (N=62, 119, 118, 126)Week 14 (N=62, 119, 118, 126)
OPC-34712 0.15 mg Fixed Dose-0.98-2.13-3.58-5.11-5.34-5.55
OPC-34712 0.5 ± 0.25 mg Low Dose-1.88-2.58-3.41-3.77-5.22-4.96
OPC-34712 1.5 ± 0.5 mg High Dose-2.04-4.08-4.82-5.77-5.65-6.74
Placebo-0.98-1.62-2.09-2.07-2.37-3.08

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Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Hamilton Depression Rating Scale (HAM-D17) Score.

"The HAM-D17 is utilized as a secondary assessment of a participant's level of depression. The HAM-D (17-Item) consists of 17 items. Eight items are rated on a 0 to 2 scale (items 4, 5, 6, 12, 13, 14, 16 and 17), while nine items (items 1, 2, 3, 7, 8, 9, 10, 11, and 15) are rated on a 0 to 4 scale (twice the weight of the other items). For all of these items, 0 is the best rating and the highest score (2 or 4) is the worst rating. The possible total scores are from 0 to 52." (NCT00797966)
Timeframe: Week 8 to Week 14

InterventionUnits on a scale (Least Squares Mean)
OPC-34712 0.15 mg Fixed Dose-5.77
OPC-34712 0.5 ± 0.25 mg Low Dose-5.28
OPC-34712 1.5 ± 0.5 mg High Dose-6.59
Placebo-5.23

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Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Q-LES-Q-SF Item 15 Score (Satisfaction With Medication).

The Q-LES-Q (Short Form) is a self-report measure designed to enable physicians to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. According to the scoring system suggested for this questionnaire, item 15 (Satisfaction with Medication) will yield a separate subscore. (NCT00797966)
Timeframe: Week 8 to Week 14

InterventionUnits on a scale (Mean)
OPC-34712 0.15 mg Fixed Dose0.02
OPC-34712 0.5 ± 0.25 mg Low Dose0.01
OPC-34712 1.5 ± 0.5 mg High Dose0.02
Placebo0.00

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Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Mean Quality of Life, Enjoyment, and Satisfaction Questionnaire - Short Form (QLES-Q-SF) Subscale Score - the Overall General Subscore (Sum of First 14 Items).

The Q-LES-Q is a self-report measure to enable physicians to obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning. Each item is scored on a five-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. Lower scores indicating less enjoyment or satisfaction with the activity. The Overall-General Subscore will be defined by summing the scores on all 14 items and expressing it as the percent of the maximum possible score. When expressing the total score as a percentage, if items are left blank the range will be modified to reflect the number of items scored. Raw score is sum of non-missing ratings from items 1 to 14. Minimum score is number of non-missing items. Maximum score is 5*(minimum score). Range is maximum score minus minimum score. Total score is 100*(Raw score minus minimum score)/ Range, rounded to nearest integer. (NCT00797966)
Timeframe: Week 8 to Week 14

InterventionPercentage of maximum possible score (Least Squares Mean)
OPC-34712 0.15 mg Fixed Dose7.60
OPC-34712 0.5 ± 0.25 mg Low Dose6.53
OPC-34712 1.5 ± 0.5 mg High Dose7.46
Placebo5.92

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Change From End of Phase A (Week 8 Visit) to End of Phase B (Week 14 Visit) in Sheehan Disability Scale (SDS) Mean Score (the Mean of 3 Individual Item Scores).

The Sheehan Disability Scale (SDS) is a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms is marked along the line from 0 = not at all, to 10 = extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The Mean SDS Score will be calculated over the three item scores. All three item scores need to be available with the exception of the work/school item score when this item is not applicable. (NCT00797966)
Timeframe: Week 8 to Week 14

InterventionUnits on a scale (Least Squares Mean)
OPC-34712 0.15 mg Fixed Dose-0.84
OPC-34712 0.5 ± 0.25 mg Low Dose-0.80
OPC-34712 1.5 ± 0.5 mg High Dose-1.27
Placebo-0.61

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Hospital Anxiety and Depression Scale (HADS)

The HADS is a patient-rated scale designed to screen for anxiety and depressive states in medical patients. It consists of two sub-scales: the D-scale measures depression and the A-scale measures anxiety. Each sub-scale contains 7 items, and each item is rated from 0 (absent) to 3 (maximum severity). The score of each sub-scale ranges from 0 to 21, and are analysed separately. The total HADS score ranges from 0 to 42. (NCT00807248)
Timeframe: Mean change from baseline to Week 8

InterventionScores on a scale (Mean)
Placebo (Orally, Once Daily)-9.7
Escitalopram 20 mg and Placebo (Orally, Once Daily)-14.7
Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)-14.1
Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)-15.0

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Clinical Global Impression - Severity of Illness (CGI-S)

The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). (NCT00807248)
Timeframe: Mean change from baseline to Week 8

InterventionScores on a scale (Mean)
Placebo (Orally, Once Daily)-1.04
Escitalopram 20 mg and Placebo (Orally, Once Daily)-1.65
Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)-1.58
Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)-1.76

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Clinical Global Impression - Global Improvement (CGI-I)

The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00807248)
Timeframe: at Week 8

InterventionScores on a scale (Mean)
Placebo (Orally, Once Daily)2.97
Escitalopram 20 mg and Placebo (Orally, Once Daily)2.21
Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)2.35
Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)2.26

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SDS: Work Subscale

The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. (NCT00807248)
Timeframe: Mean change from baseline to Week 8

InterventionScores on a scale (Mean)
Placebo (Orally, Once Daily)-2.7
Escitalopram 20 mg and Placebo (Orally, Once Daily)-3.8
Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)-3.8
Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)-4.0

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SDS: Social Subscale

The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. (NCT00807248)
Timeframe: Mean change from baseline to Week 8

InterventionScores on a scale (Mean)
Placebo (Orally, Once Daily)-2.7
Escitalopram 20 mg and Placebo (Orally, Once Daily)-3.9
Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)-3.8
Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)-4.1

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Montgomery and Åsberg Depression Rating Scale (MADRS)

The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60. (NCT00807248)
Timeframe: Baseline to 8 weeks

InterventionScores on a scale (Mean)
Placebo (Orally, Once Daily)-13.4
Escitalopram 20 mg and Placebo (Orally, Once Daily)-19.0
Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)-18.5
Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)-19.4

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Sheehan Disability Scale (SDS): Family Subscale

The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. (NCT00807248)
Timeframe: Mean change from baseline to Week 8

InterventionScores on a scale (Mean)
Placebo (Orally, Once Daily)-2.8
Escitalopram 20 mg and Placebo (Orally, Once Daily)-4.0
Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)-3.9
Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)-4.1

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MADRS

The MADRS is a 10-item rating scale designed to assess the severity of the symptoms in depressive illness and to be sensitive to treatment effects. Symptoms are rated on a 7-point scale from 0 (no symptom) to 6 (severe symptom). Definitions of severity are provided at 2-point intervals. The total score of the 10 items ranges from 0 to 60. (NCT00807248)
Timeframe: From baseline to Week 8

InterventionScores on a scale (Least Squares Mean)
Placebo (Orally, Once Daily)-13.4
Escitalopram 20 mg and Placebo (Orally, Once Daily)-19.0
Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)-18.5
Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)-19.4

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Insomnia Severity Index (ISI)

The ISI is both a brief screening measure of insomnia and an outcomes measure for use in treatment research. It is a brief self-report instrument measuring the patient's perception of his or her insomnia, and it comprises 7 items. Each item is rated on a 0-4 scale and the total score ranges from 0 to 28. 0 = no symptoms and 28 = severe symptoms. (NCT00807248)
Timeframe: Mean change from baseline to Week 8

InterventionScores on a scale (Mean)
Placebo (Orally, Once Daily)-6.9
Escitalopram 20 mg and Placebo (Orally, Once Daily)-10.0
Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)-9.6
Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)-10.6

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Time to Confirmed Remission by a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 That is Maintained for Two Consecutive Visits

Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission defined as a score on the HAMD-17 of ≤ 7 for 2 consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). (NCT00810069)
Timeframe: Week 4 through Week 16

Interventionweeks (Median)
Early Intervention12.9
Delayed InterventionNA

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Estimated Probability of Not Reaching Confirmed Response at 12 Weeks Based on the Survival Function for the Time to Confirmed Response

Survival function is estimating the probability of participants not achieving confirmed response after 12 weeks. Confirmed response is defined as >=50% change from baseline reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17). The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). (NCT00810069)
Timeframe: Week 4 through Week 16

Interventionestimated probability (percent) (Mean)
Early Intervention28
Delayed Intervention26

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Estimated Probability of Not Reaching Confirmed Remission at 12 Weeks Based on the Survival Function for the Time to Confirmed Remission

Survival function is estimating the probability of participants not achieving confirmed remission. Confirmed remission is defined as a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 that is maintained for two consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). (NCT00810069)
Timeframe: Week 4 through Week 16

Interventionestimated probability (percent) (Mean)
Early Intervention52
Delayed Intervention59

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Time to Confirmed Remission as Defined by a 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Score of ≤ 5 That is Maintained for Two Consecutive Visits.

Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission. A 16-item participant-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity. (NCT00810069)
Timeframe: Week 4 through Week 16

Interventionweeks (Median)
Early InterventionNA
Delayed InterventionNA

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Visual Analog Scale (VAS) - Overall Pain Severity

VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 10 centimeter (cm) line between two anchors (0= no pain and 10=very severe pain). (NCT00810069)
Timeframe: Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16

,
Interventionunits on a scale (Mean)
Baseline (n=282, 284)Week 4 (n=281, 283)Week 6 (n=270, 271)Week 8 (n=245, 241)Week 10 (n=207, 204)Week 12 (n=170, 181)Week 14 (n=151, 152)Week 16 (n=143, 152)
Delayed Intervention3.83.53.33.02.72.62.52.3
Early Intervention3.63.02.62.42.42.12.02.0

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Time to Confirmed Response by ≥ 50% Change From Baseline Reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17)

Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response defined as ≥ 50% baseline score reduction on the HAMD-17 for 2 consecutive visits. The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale, e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). (NCT00810069)
Timeframe: Week 4 through Week 16

Interventionweeks (Median)
Early Intervention6.4
Delayed Intervention8.0

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Sheehan Disability Scale (SDS) Normal Functioning Total Score

The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life. (NCT00810069)
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

,
Interventionunits on a scale (Mean)
Baseline (n=216, 217)Week 4 (n=215, 215)Week 8 (n=186, 188)Week 12 (n=140, 144)Week 16 (n=113, 121)
Delayed Intervention19.917.514.013.210.2
Early Intervention19.916.913.512.110.3

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Resource Utilisation - Number of Work Hours Missed in the Last 4 Weeks

Only those participants who missed at least 1 hour of work were included. (NCT00810069)
Timeframe: Week 4, Week 8, Week 12, Week 16

,
InterventionHours (Mean)
Week 4 (n=73, 89)Week 8 (n=54, 67)Week 12 (n=38, 56)Week 16 (n=25, 39)
Delayed Intervention95.0102.3104.5126.4
Early Intervention88.692.585.091.5

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Resource Utilisation - Number of Work Hours Missed Due to Depression in the Last 4 Weeks

Only those participants who missed at least 1 hour of work due to depression were included. (NCT00810069)
Timeframe: Week 4, Week 8, Week 12, Week 16

,
InterventionHours (Mean)
Week 4 (n=70, 86)Week 8 (n=47, 61)Week 12 (n=31, 52)Week 16 (n=24, 38)
Delayed Intervention95.1109.7111.4126.0
Early Intervention90.698.598.791.9

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Resource Utilisation - Number of Visits to Primary Healthcare Provider Due to Depression in the Last 4 Weeks

(NCT00810069)
Timeframe: Week 4, Week 8, Week 12, Week 16

,
InterventionVisits (Mean)
Week 4 (n=36, 55)Week 8 (n=14, 22)Week 12 (n=8, 12)Week 16 (n=4, 7)
Delayed Intervention1.61.71.61.6
Early Intervention1.51.11.32.0

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Resource Utilisation - Number of Visits to Other Specialists Due to Depression in the Last 4 Weeks

(NCT00810069)
Timeframe: Week 4, Week 8, Week 12, Week 16

,
InterventionVisits (Mean)
Week 4 (n=25, 16)Week 8 (n=8, 8)Week 12 (n=3, 2)Week 16 (n=2, 1)
Delayed Intervention1.71.91.03.0
Early Intervention2.21.61.72.0

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Resource Utilisation - Number of Hours Worked Per Week

(NCT00810069)
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

,
InterventionHours (Mean)
Week 4 (n=153, 159)Week 8 (n=136, 141)Week 12 (n=119, 115)Week 16 (n=96, 96)
Delayed Intervention38.637.738.138.0
Early Intervention37.737.937.737.2

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Resource Utilisation - Has the Participant Been Hospitalized Due to Depression in the Last 4 Weeks - Number of Participants With a Yes Response

(NCT00810069)
Timeframe: Week 4, Week 8, Week 12, Week 16

,
Interventionparticipants (Number)
Week 4Week 8Week 12Week 16
Delayed Intervention0000
Early Intervention1000

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Number of Participants With Adverse Events (AEs)

The list of AEs is located in the Reported Adverse Event module. (NCT00810069)
Timeframe: Baseline through Week 16

,
Interventionparticipants (Number)
Number of participants with adverse eventsNumber of participants with serious adverse events
Delayed Intervention1014
Early Intervention1128

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Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - United Kingdom (UK) Population Based Index Score

The EQ-5D is a generic, multidimensional, health-related, quality of life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each participant, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant. (NCT00810069)
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

,
Interventionunits on a scale (Mean)
Baseline (n=279, 282)Week 4 (n=279, 282)Week 8 (n=244, 238)Week 12 (n=168, 178)Week 16 (n=143, 153)
Delayed Intervention0.30.50.60.60.7
Early Intervention0.40.50.70.70.7

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Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - Health State Score

The EQ-5D Health State Score is self-rated health on a vertical, visual analogue scale measured in centimeters (cm) and reported as units on a scale. Best imaginable health state = 10 cm and worst imaginable health state = 0 cm. (NCT00810069)
Timeframe: Baseline, Week 4, Week 8, Week 12, Week 16

,
Interventionunits on a scale (Mean)
Baseline (n=281, 283)Week 4 (n=282, 280)Week 8 (n=244, 237)Week 12 (n=169, 177)Week 16 (n=142, 153)
Delayed Intervention3.94.55.45.86.5
Early Intervention4.24.95.75.96.5

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Clinical Global Impressions of Severity (CGI-S) Scale

Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). (NCT00810069)
Timeframe: Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16

,
Interventionunits on a scale (Mean)
Baseline (n=282, 284)Week 4 (n=281, 284)Week 6 (n=271, 277)Week 8 (n=254, 254)Week 10 (n=231, 236)Week 12 (n=203, 214)Week 14 (n=184, 194)Week 16 (n=178, 182)
Delayed Intervention4.64.33.73.32.92.72.52.2
Early Intervention4.64.33.63.22.82.62.42.2

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Time to Confirmed Response as Defined by ≥ 50% Reduction From Baseline Reduction in the 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) That is Reported for Two Consecutive Visits

Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response. QIDS16SR is a 16-item participant-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity. (NCT00810069)
Timeframe: Week 4 through Week 16

Interventionweeks (Median)
Early Intervention6.0
Delayed Intervention6.9

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Change in Relative Theta Power From Channel 4

Change between baseline and LOCF in relative power of the theta wave recorded from channel 4 of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. (NCT00824044)
Timeframe: 12 weeks

InterventionHz (Mean)
Non Responders in CBT Arm.0336
Responders in CBT Arm-.0009
Non Responders in Medication Arm.0076
Responders in Medication Arm.0070

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Change in Relative Theta Power Channel 3

Change between baseline and LOCF in relative power of the theta wave recorded from channel 3 of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. (NCT00824044)
Timeframe: 12 weeks

InterventionHz (Mean)
Non Responders in CBT Arm.0362
Responders in CBT Arm-.0090
Non Responders in Medication Arm.0015
Responders in Medication Arm.272

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Change in Relative Beta Power From Channel 4

Change between baseline and LOCF in relative power of the beetawave recorded from channel 4 of the EEG. Relative power refers to the percentage of power in the beta wave compared with the total power in the patient's EEG. (NCT00824044)
Timeframe: 12 weeks

InterventionHz (Mean)
Non Responders in CBT Arm.0483
Responders in CBT Arm.0173
Non Responders in Medication Arm.0063
Responders in Medication Arm.0179

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Change in Absolute Theta Power From Channel 1

Change between baseline and LOCF in relative power of the theta wave recorded from channel 1 of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. (NCT00824044)
Timeframe: 12 weeks

InterventionHz (Mean)
Non Responders in CBT Arm.225
Responders in CBT Arm-.0455
Non Responders in Medication Arm.0075
Responders in Medication Arm.003

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Hamilton Depression Rating Scale (HAM-D-17) Scores

The Hamilton Depression Rating Scale is a clinician-rated scale used to rate depression severity. The maximum score is a 50 and the minimum score is a 0, where higher scores indicate greater severity. Scores from 14 to 18 indicate moderately severe depression. (NCT00824044)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Cognitive Behavioral Therapy (CBT)10.64
Escitalopram13.78

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Change in Absolute Beta Power From the Ear Channel

Change between baseline and LOCF in absolute power of the beta wave recorded from the ear channel of the EEG. The ear channel refers to the average of channels 3 and 4. (NCT00824044)
Timeframe: 12 weeks

InterventionHz (Mean)
Non Responders in CBT Arm.0537
Responders in CBT Arm-.0167
Non Responders in Medication Arm.0670
Responders in Medication Arm-.01401

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Change in Absolute Beta Power in Channel 4

Change between baseline and LOCF in absolute power of the beta wave recorded from channel 4 of the EEG (NCT00824044)
Timeframe: 12 weeks

InterventionHz (Mean)
Non Responders in CBT Arm.0930
Responders in CBT Arm-.0102
Non Responders in Medication Arm.0683
Responders in Medication Arm.0056

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Change in Relative Theta Power From Ear Channel

Change between baseline and LOCF in relative power of the theta wave recorded from the ear channel of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. The ear channel refers to the average of channels 3 and 4 (NCT00824044)
Timeframe: 12 weeks

InterventionHz (Mean)
Non Responders in CBT Arm.0349
Responders in CBT Arm-.0050
Non Responders in Medication Arm.0046
Responders in Medication Arm.0171

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Change in Relative Theta Power From Temporal Channel

Change between baseline and LOCF in relative power of the theta wave recorded from the temporal channel of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. The temporal channel refers to the average of channels 1 and 2 (NCT00824044)
Timeframe: 12 weeks

InterventionHz (Mean)
Non Responders in CBT Arm.0182
Responders in CBT Arm-.0159
Non Responders in Medication Arm.0125
Responders in Medication Arm.0027

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Percent Change in Relative Theta Power From Week 1 of the Ear Channel

Percent change between baseline and week 1 in relative power of the theta wave recorded from the ear channel of the EEG. Relative power refers to the percentage of power in the theta wave compared with the total power in the patient's EEG. The ear channel refers to the average of channels 3 and 4 (NCT00824044)
Timeframe: 1 week

Interventionpercent (Mean)
Non Responders in CBT Arm44.1809
Responders in CBT Arm8
Non Responders in Medication Arm7.5180
Responders in Medication Arm23.3718

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Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Happy and Fearful Faces Are Presented in a Rapid Covert Stimulus Presentation.

Activation was measured using BOLD fMRI in response to happy and fearful faces presented in a rapid covert or masked presentation. The response following two weeks of escitalopram was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the left middle temporal gyrus. (NCT00825825)
Timeframe: two weeks

Interventionvoxels (Number)
All Participants With Complete Usable Data478

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Number of Voxels Showing Greater Activation Following Placebo Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.

Activation was measured using BOLD fMRI in response to affective words contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of placebo was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the right lingual gyrus and right superior lateral occipital cortex. (NCT00825825)
Timeframe: 2 weeks

Interventionvoxels (Number)
All Participants With Complete Usable Data619

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Number of Voxels Showing Greater Activation Following Escitalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.

Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of escitalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right inferior lateral occipital cortex. (NCT00825825)
Timeframe: 2 weeks

Interventionvoxels (Number)
All Participants With Complete Usable Data396

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Number of Voxels Showing Greater Activation Following Citalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.

Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of citalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right lateral occipital cortex. (NCT00825825)
Timeframe: 2 weeks

Interventionvoxels (Number)
All Participants With Complete Usable Data253

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Number of Voxels Showing Greater Activation Following Citalopram Compared With Placebo When Affective Faces Are Presented in a Covert Stimulus Presentation and Contrasted With a Fixation Stimulus.

Activation was measured using BOLD fMRI in response to affective (happy and fearful) faces presented in a covert or masked presentation and contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of citalopram was compared to the response following two weeks of placebo. The cluster of differential activation was located in the right occipital fusiform gyrus. (NCT00825825)
Timeframe: 2 weeks

Interventionvoxels (Number)
All Participants With Complete Usable Data658

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Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Affective Words Are Contrasted With a Fixation Stimulus.

Activation was measured using BOLD fMRI in response to affective words contrasted with activation in response to a neutral fixation stimulus. The response following two weeks of escitalopram was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the left primary visual cortex. (NCT00825825)
Timeframe: 2 weeks

Interventionvoxels (Number)
All Participants With Complete Usable Data289

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Number of Voxels Showing Greater Activation Following Escitalopram Compared With Citalopram When Faces and a Fixation Stimulus Are Presented in an Overt Presentation.

Activation was measured using BOLD fMRI in response to affective faces and a fixation stimulus presented in an overt or unmasked presentation. The response following two weeks of escitalopram was compared to the response following two weeks of citalopram. The cluster of differential activation was located in the right insular cortex. (NCT00825825)
Timeframe: 2 weeks

Interventionvoxels (Number)
All Participants With Complete Usuable Data735

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Change in Clinician-rated Montgomery-Asberg Depression Rating Scale (MADRS)

The Montgomery-Åsberg Depression Rating Scale is a widely used 10-item clinician-rated scale that describes the severity of depressive symptoms (range 0-60, higher score indicates greater symptom burden). (NCT00833469)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
Escitalopram-21.33

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Change in Edinburgh Postnatal Depression Scale (EPDS)

The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-report used to measure postpartum depression (range 0-30, higher score indicates greater symptom burden). A score of >9 is indicative of perinatal major depression. (NCT00833469)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
Escitalopram-19.33

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Change in Beck Anxiety Inventory (BAI)

Beck Anxiety Inventory (BAI): The BAI is a 21-item self-report questionnaire measuring typical symptoms of anxiety during the past week (range 0-63, higher score indicates greater anxiety). (NCT00833469)
Timeframe: 8 weeks

Interventionunits on a scale (Mean)
Escitalopram-15.00

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Recruitment Feasibility, Defined as the Number of Participants Recruited and Administered a Medication Dose Within 48 Hours of Mechanical Ventilation

(NCT00872027)
Timeframe: Measured within 2 days of participant recruitment

Interventionparticipants (Number)
Participants Will Receive 8 Weeks of Escitalopram Treatment.7
Participants Will Receive 8 Weeks of Placebo Pills.8

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Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS)

"Scoring:~Participants rate the extent to which work, social life, and home life are impaired by his or her symptoms. A 10 point scale is used where 0= not impaired and 10 is highly impaired indicating. The three aspects of life can be summed up into a single dimensional measure of global functional impairment that indicates 0= not impaired and 30 = highly impaired. Scores of 5 or greater are on any of the three scales are considered significant." (NCT00887679)
Timeframe: baseline and 7 weeks

Interventionunits on a scale (Mean)
Escitalopram0

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Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE)

Mini Mental State Examination (MMSE),a low score less than or equal to 23 indicates cognitive impairment and the need for further evaluation; normal cognitive function = 27-30, mild cognitive impairment = 21-26, moderate cognitive impairment = 11-20, and severe cognitive impairment = 0-10. The highest possible score is 30. (NCT00887679)
Timeframe: baseline and 7 weeks

Interventionunits on a scale (Mean)
Escitalopram0

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Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I)

"Scale for scoring:~Clinical Global Impression(CGI-S)~= Normal, no symptoms~= Borderline ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Most extremely ill~Clinical Global Impression(CGI-I)-improvement since treatment~very much improved~much improved~minimally improved~no change from baseline~minimally worse~much worse~very much worse" (NCT00887679)
Timeframe: baseline and 7 weeks

Interventionscores on a scale (Mean)
Clinical Global Impression (CGI-I)Clinical Global Impression (CGI-S)
Escitalopram12

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Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory

"Scoring~The BDI consist of twenty-one questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answer choices, ranging in intensity as follows:~(0) I do not feel sad.~I feel sad.~I am sad all the time and I can't snap out of it.~I am so sad or unhappy that I can't stand it.~A value of 0 to 3 is assigned for each answer and the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:[6] 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression.~Higher total scores indicate more severe depressive symptoms." (NCT00887679)
Timeframe: baseline and 7 weeks

Interventionunits on a scale (Mean)
Escitalopram27.8

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Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)

The HAM-A is administered by an interviewer who asks a series of questions related to symptoms of anxiety. The interviewer then rates the individual on a five-point scale for each of the 14 items. Seven of the items specifically address psychic anxiety and the remaining seven items address somatic anxiety. The total anxiety score ranges from 0 to 56, lower scores are better. Change from randomization to end of treatment in scores on the Hamilton Anxiety Rating Scale (HAM-A)is measured. (NCT00887679)
Timeframe: baseline and 7 weeks

Interventionscores on an anxiety scale (Mean)
Escitalopram21.23

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Change From Randomization to End of Treatment for Trail Making Tet (TMT)

"Trail Making Test (TMT)Results for TMT are reported as the number of seconds required to complete the task. Higher scores reveal greater impairment.~Average =29 seconds, Deficient > 78 seconds" (NCT00887679)
Timeframe: baseline to 7 weeks

Interventionseconds (Mean)
Escitalopram29.2

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Change in Daily Severity of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries

Change in daily hot flash severity between baseline & week 8 was calculated as mean difference. Baseline severity ratings were calculated as daily mean ratings for the first two screening weeks pre-baseline. Week 8 severity ratings were calculated as daily mean ratings during the week before week 8. Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment. Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN). (NCT00894543)
Timeframe: week 8 minus baseline

InterventionScores on a scale (Mean)
Escitalopram-0.53
Placebo-0.30

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Change in Daily Frequency of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries

Change in daily hot flash frequency was calculated as the daily mean difference between baseline and week 4. Baseline was calculated as the daily mean of the daily frequencies for the first two screening weeks. Week 4 was calculated as the daily mean of the daily frequencies during the week prior to the week 4 visit. (NCT00894543)
Timeframe: week 4 minus baseline

InterventionHot flashes/day (Mean)
Escitalopram-4.37
Placebo-2.49

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Daily Hot Flash Bother, Recorded on Daily Diaries

"Daily Hot flash bother scores were calculated by selecting the highest bother rating for hot flashes or night sweats for each woman in each 24-hour day. The score was set to missing on on any day data were missing or or hot flashes equaled 0. The daily mean of daily ratings for the first 2 screening weeks is reported.~Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), or 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN)." (NCT00894543)
Timeframe: Baseline

InterventionScores on a scale (Mean)
Escitalopram3.12
Placebo3.16

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Secondary Outcome: Change in Daily Hot Flash Bother Between Baseline and Week 8 as Recorded on Daily Diaries

Change in daily hot flash bother between baseline & week 8 was calculated as mean difference. Baseline daily bother was the mean of the highest daily ratings for two screening weeks pre-baseline. Week 8 bother was daily mean of the highest daily bother ratings during the week before week 8. Modified intention to treat analysis included all randomized participants who provided diary data, which were analyzed regardless of adherence to treatment assignment. Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN). (NCT00894543)
Timeframe: week 8 minus baseline

InterventionScores on a scale (Mean)
Escitalopram-0.63
Placebo-0.39

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Change in Daily Severity of Hot Flashes Between Baseline and Week 4 as Assessed by Prospective Daily Diaries

"Change in daily hot flash severity from baseline to week 4 was calculated as the mean difference in hot flash severity ratings between baseline and week 4. Baseline was calculated as the daily mean from the first two weeks of hot flash severity ratings. Week 4 severity ratings were calculated as the daily mean from the ratings for the week prior to the week 4 visit.~Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN)." (NCT00894543)
Timeframe: week 4 minus baseline

InterventionScores on a scale (Mean)
Escitalopram-0.43
Placebo-0.23

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Daily Frequency of Hot Flashes Per Day Assessed by Prospective Daily Diaries

Baseline hot flash frequency per day was calculated as the daily mean of the daily totals reported during the first two screening weeks. (NCT00894543)
Timeframe: Baseline

InterventionHot flashes/day (Mean)
Escitalopram9.88
Placebo9.66

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Daily Severity of Hot Flashes Assessed by Prospective Daily Diaries

"Daily hot flash severity scores were calculated by by selecting the highest severity rating for hot flashes or night sweats for each woman in each 24-hour day. The score was set to missing on on any day data were missing or or hot flashes equaled 0. The daily mean of daily ratings for the first 2 screening weeks is reported.~Hot flash severity was rated as 1 (mild), 2 (moderate), or 3 (severe) as adopted from the Study of Women Across the Nation (SWAN)." (NCT00894543)
Timeframe: Baseline

InterventionScores on a scale (Mean)
Escitalopram2.16
Placebo2.19

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Change in Daily Hot Flash Bother Between Baseline and Week 4 as Recorded on Daily Diaries

"Change in daily hot flash bother was calculated as the mean difference between baseline and week 4. Baseline was calculated as the daily mean of the highest daily bother ratings during the first two screening weeks. Week 4 was calculated as the daily mean of the highest of the daily bother ratings during the week prior to the week 4 visit.~Hot flash bother was rated as 1 (none), 2 (a little), 3 (moderately), or 4 (a lot) as adopted from the Study of Women Across the Nation (SWAN)." (NCT00894543)
Timeframe: week 4 minus baseline

InterventionScores on a scale (Mean)
Escitalopram-0.59
Placebo-0.29

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Change in Daily Frequency of Hot Flashes Between Baseline and Week 8 as Assessed by Prospective Daily Diaries

Change in daily hot flash frequency was calculated as the daily mean difference between baseline and week 8. Baseline was calculated as the daily mean of the frequencies for the first two screening weeks. Week 8 was calculated as the daily mean of the daily frequencies during the week prior to the week 8 visit. (NCT00894543)
Timeframe: week 8 minus baseline

InterventionHot flashes/day (Mean)
Escitalopram-4.60
Placebo-3.20

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Percentage of Patients Who Achieved Remission After 12 Weeks of Treatment Using CGI-S <= 2

The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). (NCT00902226)
Timeframe: baseline and 12 weeks

Interventionpercentage of patients (Number)
Escitalopram (5 to 20 mg Oral Tablets Daily)60

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Percentage of Patients Who Responded to Escitalopram After 12 Weeks of Treatment Using CGI-I <= 2

The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00902226)
Timeframe: baseline and 12 weeks

Interventionpercentage of patients (Number)
Escitalopram (5 to 20 mg Oral Tablets Daily)80

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Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Social

The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. (NCT00902226)
Timeframe: baseline and 12 weeks

Interventionscores on a scale (Mean)
Escitalopram (5 to 20 mg Oral Tablets Daily)3.5

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Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Family

The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. (NCT00902226)
Timeframe: baseline and 12 weeks

Interventionscores on a scale (Mean)
Escitalopram (5 to 20 mg Oral Tablets Daily)2.2

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Effect of Escitalopram After 12 Weeks Using Sheehan Disability Scale (SDS) Work

The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scales, on which 0 = normal functioning and 10 = severe functional impairment. (NCT00902226)
Timeframe: baseline and 12 weeks

Interventionscores on a scale (Mean)
Escitalopram (5 to 20 mg Oral Tablets Daily)3.8

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Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-I)

The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00902226)
Timeframe: baseline and 12 weeks

Interventionscores on a scale (Mean)
Escitalopram (5 to 20 mg Oral Tablets Daily)2.1

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Effect of Escitalopram After 12 Weeks Using the Clinical Global Impression (CGI-S)

The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). (NCT00902226)
Timeframe: baseline and 12 weeks

Interventionscores on a scale (Mean)
Escitalopram (5 to 20 mg Oral Tablets Daily)2.6

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Effect of Escitalopram After 8 Weeks of Treatment in Patients With GAD Using the Hamilton Anxiety Scale (HAMA)

The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56. (NCT00902564)
Timeframe: baseline and 8 weeks

Interventionscores on a scale (Mean)
Escitalopram (5 to 20 mg Oral Tablets Daily)13.1

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Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Family

The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment. (NCT00902564)
Timeframe: baseline and 8 weeks

Interventionscores on a scale (Mean)
Escitalopram (5 to 20 mg Oral Tablets Daily)1.2

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Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Work

The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment. (NCT00902564)
Timeframe: baseline and 8 weeks

Interventionscores on a scale (Mean)
Escitalopram (5 to 20 mg Oral Tablets Daily)2.0

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Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-I)

The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00902564)
Timeframe: baseline and 8 weeks

Interventionscores on a scale (Mean)
Escitalopram (5 to 20 mg Oral Tablets Daily)1.2

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Effect of Escitalopram After 8 Weeks Using the Clinical Global Impression (CGI-S)

The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). (NCT00902564)
Timeframe: baseline and 8 weeks

Interventionscores on a scale (Mean)
Escitalopram (5 to 20 mg Oral Tablets Daily)1.9

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Percentage of Patients Who Achieved Remission After 8 Weeks of Treatment Using CGI-S <= 2

The CGI-S provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (Normal - not at all ill) to 7 (among the most extremely ill patients). (NCT00902564)
Timeframe: baseline and 8 weeks

Interventionpercentage of patients (Number)
Escitalopram (5 to 20 mg Oral Tablets Daily)85.7

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Percentage of Patients Who Responded According to >= 50% Improvement From Baseline to Week 8 in HAMA Total Score

The HAMA is a 14-item rating scale designed to assess global anxiety symptoms. Each symptom is rated from 0 (absent) to 4 (severe). The total score of the 14 items ranges from 0 to 56. (NCT00902564)
Timeframe: baseline and 8 weeks

Interventionpercentage of patients (Number)
Escitalopram (5 to 20 mg Oral Tablets Daily)67.9

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Percentage of Patients Who Responded to Escitalopram After 8 Weeks of Treatment Using CGI-I <= 2

The CGI-I provides the clinician's impression of the patient's improvement (or worsening). The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). (NCT00902564)
Timeframe: baseline and 8 weeks

Interventionpercentage of patients (Number)
Escitalopram (5 to 20 mg Oral Tablets Daily)100

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Effect of Escitalopram After 8 Weeks Using Sheehan Disability Scale (SDS) Social

The SDS comprises self-rated items designed to measure impairment. The patient rates the extent to which his or her (1) work, (2) social life or leisure activities and (3) home life or family responsibilities are impaired on a 10-point visual analogue scale, on which 0 = normal functioning and 10 = severe functional impairment. (NCT00902564)
Timeframe: baseline and 8 weeks

Interventionscores on a scale (Mean)
Escitalopram (5 to 20 mg Oral Tablets Daily)1.7

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WHODAS-II Disability Scale

A disability rating scale published by the World Health Organization, the WHODAS II total scores can range from 0-100. Higher scores indicate greater severity of disability. Total scores are reported with no subscales. (NCT00918684)
Timeframe: 14 weeks (12th week of treatment)

Interventionunits on a scale (Mean)
Escitalopram31.43

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Stroop Color-Word Test

A published and widely used executive dysfunction test, the Stroop Color-Word total scores can range from 0-100. Higher scores indicate better memory functioning (no cognitive impairment). Total scores are reported with no subscales. (NCT00918684)
Timeframe: 14 weeks (12th week of treatment)

Interventionunits on a scale (Mean)
Escitalopram33.63

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Hamilton Depression Rating Scale.

A published and widely-used scale for rating depression severity, the Hamilton Depression Rating Scale 24 item total scores range from 0-76. Higher scores indicate greater severity of depression. Total scores are reported with no subscales. (NCT00918684)
Timeframe: 14 weeks (12th week of treatment)

Interventionunits on a scale (Mean)
Escitalopram8.09

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Number of Participants Meeting Depression Remission Criteria

Depression remission defined as 3 consecutive weeks of HRSD-17 scores that on average, < or = 7 (NCT00930293)
Timeframe: Measured at baseline and weekly for up to 20 weeks of acute treatment

Interventionparticipants (Number)
Personalized Depression Care10
Standard Depression Care15

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Weeks to Depression Remission

"Kaplan-Meier survival analyses to determine time to depression remission (defined as average HRSD-17 score < or = 7 for three consecutive weeks).~Analyses run with the full intent to treat sample (censoring patients who dropped out at time of termination)" (NCT00930293)
Timeframe: Measured at baseline and weekly for up to 20 weeks of treatment

Interventionweeks (Mean)
Personalized Depression Care13.99
Standard Depression Care11.59

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Fluorodopa Uptake Values in Brain Images of Aripiprazole Augmentation Responders

A ratio of the image derived radioactivity concentration and the whole body concentration of the injected radioactivity specifically in a cluster within the right medial caudate (see data below). (NCT00953745)
Timeframe: Week 10 and Week 16 (6 weeks of combined therapy)

,
InterventionFDOPA ratio in the right medial caudate (Mean)
Week 10Week 16
ARP Non-Responders1.3631.350
ARP Responders1.2971.333

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Depression Symptom Change on The Montgomery-Åsberg Depression Rating (MADRS) Scale Between ARP Responders and Non-responders.

Montgomery-Åsberg Depression Rating (MADRS) Scale scores compared between the 6 week Aripiprazole augmentation groups (responds vs. non-responders). Total range of the MADRS is 0 to 60, with a score of greater than 34 indicating severe depression, 20-34 indicating moderate depression, 7-19 mild depression, and 0-6 normal or absent of symptoms. (NCT00953745)
Timeframe: Week 10 and Week 16 (6 weeks of combined therapy)

,
Interventionscore on the MADRS scale (Mean)
Week 10Week 16
ARP Non-Responders31.725.3
ARP Responders27.96.5

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Fasting Blood Glucose

Fasting glucose levels collected at Baseline and Week 8. Normal range for fasting glucose is 70-110 mg/dl. (NCT00955474)
Timeframe: 8 weeks

,
Interventionml/dl (Mean)
BaselineWeek 8
Quetiapine91.689.1
Quetiapine and SSRI89.496.8

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Depression

Depression measured with Hamilton Rating Scale for Depression 17 (HAM-D) at baseline and 8 weeks. Ham D 17 scores range from 0-52, 52 being the most severe. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineLast visit
Quetiapine279.57
Quetiapine With SSRI26.7310.14

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CPFQ (Cognitive and Psychological Functioning Questionnaire)

Score on the Cognitive and Psychological Functioning Questionnaire (CPFQ). Scores range from 7-42 with 42 referring to the worst functioning. CPFQ measured at baseline and 8 weeks. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineLast visit
Quetiapine30.823.56
Quetiapine With SSRI29.321.00

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Blood Level of Triglycerides at Baseline and Week 8.

Level of triglycerides at Baseline and Week 8. Normal range: 40-150mg/dl. (NCT00955474)
Timeframe: 8 weeks

,
Interventionmg/dl (Mean)
BaselineWeek 8
Quetiapine144.9170.6
Quetiapine With SSRI154.25190.5

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Blood Level of Total Cholesterol Levels Were Collected at Baseline and Week 8.

Cholesterol levels were collected at Baseline and Week 8. Normal cholesterol levels should be <200mg/dl. (NCT00955474)
Timeframe: 8 weeks

,
Interventionmg/dl (Mean)
BaselineWeek 8
Quetiapine184.2188
Quetiapine With SSRI171.8201.7

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Blood Hemoglobin A1C at Baseline and Week 8.

Blood hemoglobin A1C at Baseline and Week 8. Normal range: 3.8%-6.4%. (NCT00955474)
Timeframe: 8 weeks

,
Intervention% glycated hemoglobin (Mean)
BaselineWeek 8
Quetiapine5.65.4
Quetiapine With SSRI5.75.8

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LDL Blood Levels at Baseline and Week 8.

LDL levels at Baseline and Week 8. Normal range < 100 mg/dl. (NCT00955474)
Timeframe: 8 weeks

,
Interventionmg/dl (Mean)
BaselineWeek 8
Quetiapine109121.1
Quetiapine With SSRI94.6123.3

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RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Visuospatial/Constructional Sub-scale.

RBANS Visuospatial/Constructional sub-scales at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineWeek 8
Quetiapine70.670.5
Quetiapine With SSRI75.678.3

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RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Total Score

Neuropsychological Assessment. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. RBANS measured at baseline and 8 weeks. (NCT00955474)
Timeframe: 8

,
Interventionunits on a scale (Mean)
BaselineLast visit
Quetiapine77.3877.25
Quetiapine With SSRI70.0078.29

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RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Language Sub-scale Score.

RBANS Language sub-scale scores at Baseline and Week 8 of study. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineWeek 8
Quetiapine80.487.9
Quetiapine With SSRI77.691.1

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RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Immediate Memory Sub-scale Score

RBANS Immediate Memory sub-scale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineWeek 8
Quetiapine83.382.8
Quetiapine With SSRI71.177.9

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HDL Blood Levels at Baseline and Week 8.

HDL levels at Baseline and Week 8. Normal range: 35-100 mg/dl. (NCT00955474)
Timeframe: 8 weeks

,
Interventionmg/dl (Mean)
BaselineWeek 8
Quetiapine47.740.8
Quetiapine With SSRI45.340.5

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RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Delayed Memory Subscale Scores at Baseline and Week 8.

RBANS Delayed Memory subscale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineWeek 8
Quetiapine82.472.9
Quetiapine With SSRI69.674.7

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RBANS (Repeatable Battery for Assessment of Neuropsychological Status) Attention Sub-scale Scores at Baseline and Week 8.

RBANS Attention sub-scale scores at Baseline and Week 8. Scores range from 40-160, with 160 referring to higher cognitive functioning. All RBANS subscales and the total score are standardized using age-based norms. Thus, they have a mean of 100 (average) and a standard deviation of 15. A score of 90-110 is in the average range; score of 70-85 mild to moderate cognitive impairment; score <70 moderate to severe impairment. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineWeek 8
Quetiapine95.8104.6
Quetiapine With SSRI85.486.1

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Psychosis

Psychosis measured by Brief Psychosis Rating Scale (BPRS) at baseline and 8 weeks. Scores range from 24-168, with 168 bring the most severe. (NCT00955474)
Timeframe: 8 weeks

,
Interventionunits on a scale (Mean)
BaselineLast visit
Quetiapine56.0934.25
Quetiapine With SSRI60.4532.83

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McGill Quality of Life Scale (MQOL)

McGill Quality of Life Scale is a a 20-item scale measuring quality of life in chronic and end of life conditions. MQOL is self-reported with a 2-day time frame. Items are scored 0 (worst) to 10 (excellent)on five domains (physical well-being, physical symptoms, psychological, existential, and support). An overall index score can be calculated from the means of the five sub-scales measuring quality of life from 0 (poor) to 10 (excellent). (NCT00965497)
Timeframe: 8 weeks

Interventionquality of life (Mean)
Escitalopram5

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Hamilton Depression Scale (HAM-D 17).

Hamilton Depression Rating Scale-17 (HAM-D) is a 17-item observer rated scale that measures depressive symptoms. Items are rated 0 (no symptoms)-4 ( most severe symptoms. Possible minimum and maximum scores range is 0-50. total score indications: 0-7 = Normal; 8-13 = Mild Depression; 14-18 = Moderate Depression; 19-22 = Severe Depression and ≥ 23 = Very Severe Depression. (NCT00965497)
Timeframe: 8 weeks

Interventiondepression severity (Median)
Escitalopram15

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Change From Baseline in the Apathy Evaluation Scale - Clinician Rated Version (AES-C) Total Score at Week 8

The AES-C is a validated 18-item instrument used to assess cognitive, behavioral, emotional and other symptoms of apathy. Clinicians rate each item based on verbal and nonverbal information provided by the participant. Item scores range from 1 (not at all characteristic) to 4 (a lot characteristic). Total scores range from 18 to 72 where higher derived scores indicate more severe apathy. The Least Squares (LS) Mean Value was calculated from a mixed model repeated measures (MMRM) model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit. (NCT00985504)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Duloxetine-13.88
Escitalopram-13.50

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Change From Baseline in the Clinical Global Impression of Severity (CGI-S) Rating Scale at Week 8

The CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit. (NCT00985504)
Timeframe: Baseline, 8 weeks

Interventionunits on a scale (Least Squares Mean)
Duloxetine-0.86
Escitalopram-0.93

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Number of Days From Baseline to Relapse as Defined by Montgomery-Asberg Depression Rating Scale (MADRS) Total Score ≥16 During 8 Weeks

The number of days from baseline to the first relapse is defined as reaching a MADRS Total Score≥16. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Censored participants were included in the Kaplan-Meier analysis, the minimum and maximum time to relapse have been calculated and reported here. Median time to relapse and quartiles could not be computationally calculated using the Kaplan-Meier procedure due to low event rate and high completion rate (censored). (NCT00985504)
Timeframe: Baseline through 8 weeks

,
Interventiondays (Number)
Minimum Number of Days from BaselineMaximum Number of Days from Baseline
Duloxetine4.0081.00
Escitalopram4.0068.00

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Patient's Global Impressions of Improvement Scale (PGI-I) Rating Scale Score at Week 8

The PGI-I is a scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, and treatment*visit. (NCT00985504)
Timeframe: 8 weeks

Interventionunits on a scale (Least Squares Mean)
Duloxetine2.59
Escitalopram2.55

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Percentage of Participants Who Discontinue Due to Lack of Efficacy During 8 Weeks

Percentage of participants who discontinue after baseline due to lack of efficacy in the investigator's opinion. (NCT00985504)
Timeframe: Baseline through 8 weeks

Interventionpercentage of participants (Number)
Duloxetine2.0
Escitalopram1.3

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Percentage of Participants Who Relapsed During 8 Weeks

Relapse is defined as achieving a Montgomery-Asberg Depression Rating Scale (MADRS) total score≥16 at any time after baseline. The MADRS is a rating scale for severity of depressive mood symptoms. The MADRS has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). (NCT00985504)
Timeframe: Baseline through 8 weeks

Interventionpercentage of participants (Number)
Duloxetine11.9
Escitalopram11.0

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Change From Baseline in the Apathy Evaluation Scale-Clinician Rated Version (AES-C) Subscale Scores at Week 8

AES-C subscales separately assess participants' intensity of cognitive, behavioral, emotional, and other apathy symptoms with individual item scores of 1 (not at all characteristic) to 4 (a lot characteristic). Subtotal score ranges for the subscales are: 8-32 (cognitive), 5-20 (behavioral), 2-8 (emotional), and 3-12 for other (display of personal insight, initiative and motivation). Higher subscale scores indicate greater illness severity. The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit. (NCT00985504)
Timeframe: Baseline, 8 weeks

,
Interventionunits on a scale (Least Squares Mean)
Cognition Items Total ScoreBehavior Items Total ScoreEmotional Items Total ScoreOther Items Total Score
Duloxetine-6.49-3.35-1.66-2.43
Escitalopram-6.25-3.25-1.58-2.44

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Change From Baseline in the Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (MGH-CPFQ) Total and Item Scores at Week 8

"The MGH-CPFQ is a 7-item participant-rated questionnaire evaluating the participant's cognitive and physical well-being during the past month. The MGH-CPFQ assesses motivation, wakefulness, energy, focus, recall, word-finding difficulty, and mental acuity. Each item is scored on a 6-point scale ranging from 1 (greater than normal) to 2 (normal) to 6 (totally absent). Total scores range from 7 to 42. Higher scores indicate greater disease severity. The LS Mean Value was calculated from an analysis of covariance (ANCOVA) model with terms of treatment, pooled investigator, and baseline." (NCT00985504)
Timeframe: Baseline, 8 weeks

,
Interventionunits on a scale (Least Squares Mean)
Total ScoreMotivation/Interest/Enthusiasm ScoreWakefulness/Alertness ScoreEnergy ScoreAbility to Focus/Sustain Attention ScoreAbility to Remember/Recall Information ScoreAbility to Find Words ScoreSharpness/Mental Acuity Score
Duloxetine-6.96-1.34-0.96-1.28-0.99-0.91-0.69-0.79
Escitalopram-6.91-1.35-1.00-1.21-1.02-0.85-0.71-0.85

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Change From Baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score and Item 8 (Inability to Feel) at Week 8

MADRS is a rating scale for severity of depressive mood symptoms and has a 10-item checklist. Items are rated on a scale of 0-6, for a total score range of 0 (low severity of depressive symptoms) to 60 (high severity of depressive symptoms). Item 8 assesses the participant's inability to feel. Scores range from 0 (normal interest in surroundings and other people) to 6 (emotional paralysis, inability to feel anger/grief/pleasure). The LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit. (NCT00985504)
Timeframe: Baseline, 8 weeks

,
Interventionunits on a scale (Least Squares Mean)
Total ScoreItem 8 (Inability to Feel)
Duloxetine-4.21-1.01
Escitalopram-4.14-0.90

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Change From Baseline in the Rothschild Scale for Antidepressant Tachyphylaxis (RSAT) Total and Individual Item Scores at Week 8

RSAT assesses symptoms of apathy or decreased motivation among depressed participants who have achieved symptomatic remission with antidepressant treatment and consists of 6 self-report items assessing energy level, motivation and interest, cognitive functioning, weight gain, sleep and sexual functioning, as well as affect. Each item score ranges from 0 to 4 with total scores ranging from 0 to 28. Higher scores indicate greater disease severity. LS Mean Value was calculated from an MMRM model with terms of treatment, pooled investigator, visit, treatment*visit, baseline, and baseline*visit. (NCT00985504)
Timeframe: Baseline, 8 weeks

,
Interventionunits on a scale (Least Squares Mean)
RSAT Total ScoreEnergy LevelMotivation and InterestCognitive FunctioningWeight GainSleepSexual FunctioningAffect
Duloxetine-5.50-1.33-1.41-0.90-0.25-0.48-0.62-0.53
Escitalopram-4.98-1.19-1.29-0.80-0.11-0.55-0.60-0.50

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Change From Baseline in the Sheehan Disability Scale (SDS) Total and Individual Scores at Week 8

The SDS is a participant-rated assessment. Total scores range from 0-30 with higher values indicating greater disruption in the participant's work/social/family life. Items 1-3 assess the effect of the participant's symptoms on work/school schedule, social life/leisure activities, and family life/home responsibilities, respectively. Item scores are 0-10; higher values indicate greater disruption. Number of unproductive days and days lost in past week (symptom related) were reported. LS Mean Value was calculated from an ANCOVA model with terms of treatment, pooled investigator, and baseline. (NCT00985504)
Timeframe: Baseline, 8 weeks

,
Interventionunits on a scale (Least Squares Mean)
SDS Total ScoreSDS Work ScoreSDS Family Score (N=212, 210)SDS Social Score (N=212, 210)SDS Days Lost Score (N=208, 204)SDS Days Unproductive Score (N=209, 205)
Duloxetine-7.55-2.42-2.51-2.56-0.55-1.78
Escitalopram-7.67-2.29-2.67-2.72-0.60-1.89

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Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score Change From Baseline to Week 4.

MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). Change from baseline was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)] (NCT01020799)
Timeframe: Baseline, Week 4

Interventionscores on a scale (Least Squares Mean)
AZD7268-11.78
Placebo-11.45
Escitalopram-11.70

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Clinical Global Impression - Severity (CGI-S) Score Change From Baseline

"CGI-S assesses global illness severity, i.e. the patient's current clinical state, on a continuous scale from 1 (Normal, not ill) to 7 (Among the most extremely ill patients). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)]" (NCT01020799)
Timeframe: Baseline, Week 4

Interventionscores on a scale (Least Squares Mean)
AZD7268-1.26
Placebo-1.15
Escitalopram-1.31

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Hamilton Rating Scale for Anxiety (HAM-A) Total Score Change From Baseline

HAM-A total score, sum of 14 item scores (each on a 0 to 4 scale), assesses the severity of anxiety symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)] (NCT01020799)
Timeframe: Baseline, Week 4

Interventionscores on a scale (Least Squares Mean)
AZD7268-5.30
Placebo-4.66
Escitalopram-6.15

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Hamilton Rating Scale for Depression (HAM-D) Total Score Change From Baseline to Week 4.

HAM-D total score, sum of 17 item scores (each on a 0 to 2 or 0 to 4 scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 52 (the worst). Change from baseline to Week 4 was calculated as Week 4 value minus baseline value. [observed cases, Mixed Model Repeated Measurement (MMRM), Full Analysis Set (FAS)] (NCT01020799)
Timeframe: Baseline, Week 4

Interventionscores on a scale (Least Squares Mean)
AZD7268-9.22
Placebo-9.15
Escitalopram-9.84

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Montgomery-Åsberg Depression Rating Scale (MADRS) Remission

Number of patients, who achieved MADRS remission at week 4. Remission is defined as a MADRS total score <= 10. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS remission at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)] (NCT01020799)
Timeframe: Week 4

InterventionParticipants (Number)
AZD726820
Placebo12
Escitalopram10

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Montgomery-Åsberg Depression Rating Scale (MADRS) Response

Number of patients with MADRS response at Week 4. MADRS response is defined as >=50% reduction in MADRS total score from baseline. MADRS total score, sum of 10 item scores (each on a 0 (best value) to 6 (worst value)scale), assesses the severity of depressive symptoms on a continuous scale from 0 (the best) to 60 (the worst). MADRS response at Week 4 is calculated using last observation carried forward (LOCF). [Full Analysis Set (FAS)] (NCT01020799)
Timeframe: Week 4

InterventionParticipants (Number)
AZD726831
Placebo31
Escitalopram14

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Phase C: Mean Clinical Global Impression - Improvement (CGI-I) Scale Score at the End of Phase C (Week 14)

CGI-I is a 7-point clinician-rated scale ranging from 1 to 7, rated as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. A higher score indicates greater impairment. (NCT01111539)
Timeframe: Week 14

Interventionscore on a scale (Mean)
Phase C: Aripiprazole/Escitalopram Combination2.6
Phase C: Escitalopram Monotherapy2.9
Phase C: Aripiprazole Monotherapy3.0

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Phase C: Mean Change From End of Phase B (Week 8) in the Sheehan Disability Scale (SDS) Mean Score to End of Phase C (Week 14)

SDS is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. The participant is asked to rate the degree to which their functioning is impaired on an 11-point scale, ranging from 0 (not at all) to 10 (extremely). The scores for the 3 domains are summed into a total score that ranges from 0 (unimpaired) to 30 (highly impaired). A higher score indicates greater impairment. A negative change from Week 8 indicates improvement. (NCT01111539)
Timeframe: Week 8 to Week 14

Interventionscore on a scale (Least Squares Mean)
Phase C: Aripiprazole/Escitalopram Combination-1.2
Phase C: Escitalopram Monotherapy-1.2
Phase C: Aripiprazole Monotherapy-0.2

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Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14)

The MADRS assessed severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms). Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). A negative change from Week 8 indicates improvement. (NCT01111539)
Timeframe: Week 8 to Week 14

Interventionscore on a scale (Least Squares Mean)
Phase C: Aripiprazole/Escitalopram Combination-8.0
Phase C: Escitalopram Monotherapy-7.0
Phase C: Aripiprazole Monotherapy-4.3

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Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14)

The MADRS assessed severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms). Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). A negative change from Week 8 indicates improvement. Last observation carried forward (LOCF) method was used for analyses. (NCT01111552)
Timeframe: Week 8 to Week 14

Interventionscore on a scale (Least Squares Mean)
Phase C: Escitalopram Monotherapy-8.0
Phase C: Aripiprazole Monotherapy-9.6
Phase C: Aripiprazole/Escitalopram Combination Therapy-9.2

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Phase C: Mean Change From End of Phase B (Week 8) in the Sheehan Disability Scale (SDS) Mean Score to End of Phase C (Week 14)

The SDS is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point continuum (0= no impairment to 10= most severe) with the total SDS score ranging from 0 (no impairment) to 30 (most severe). A negative change from Week 8 indicates improvement. Last observation carried forward (LOCF) method was used for analyses. (NCT01111552)
Timeframe: Week 8 to Week 14

Interventionscore on a scale (Least Squares Mean)
Phase C: Escitalopram Monotherapy-0.9
Phase C: Aripiprazole Monotherapy-1.4
Phase C: Aripiprazole/Escitalopram Combination Therapy-1.2

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Phase C: Clinical Global Impression - Improvement Scale (CGI-I) Score at The End of Phase C (Week 14)

The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse. Last observation carried forward (LOCF) method was used for analyses. (NCT01111552)
Timeframe: Week 14

Interventionscore on a scale (Mean)
Phase C: Escitalopram Monotherapy2.4
Phase C: Aripiprazole Monotherapy2.3
Phase C: Aripiprazole/Escitalopram Combination Therapy2.3

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Phase C: Clinical Global Impression - Improvement Scale (CGI-I) Score at the End of Phase C

CGI-I is a 7-point clinician-rated scale ranging from 1 to 7, rated as 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse. A higher score indicates greater impairment. LOCF method was used for analyses. (NCT01111565)
Timeframe: Week 14

Interventionscore on a scale (Mean)
Phase C: Aripiprazole/Escitalopram Combination2.5
Phase C: Escitalopram Monotherapy3.0
Phase C: Aripiprazole Monotherapy2.9

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Phase C: Mean Change From End of Phase B (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score to End of Phase C (Week 14)

The MADRS assessed severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms). Participants are rated on 10 items (feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and a lack of interest) each on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). A negative change (or decrease) from baseline indicates a reduction (or improvement) in symptoms. Last observation carried forward (LOCF) method was used for analyses. (NCT01111565)
Timeframe: Week 8 to Week 14

Interventionscore on a scale (Least Squares Mean)
Phase C: Aripiprazole/Escitalopram Combination-9.0
Phase C: Escitalopram Monotherapy-3.6
Phase C: Aripiprazole Monotherapy-3.8

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Phase C: Mean Change From End of Phase B (Week 8) in the Sheehan Disability Scale (SDS) Mean Score to End of Phase C (Week 14)

SDS is a 3-item clinician-rated questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. The participant is asked to rate the degree to which their functioning is impaired on an 11-point scale, ranging from 0 (not at all) to 10 (extremely). Scores of 0 to 3 indicate mild functional impairment, 4 to 6 indicate moderate functional impairment, and 7 to 9 indicate marked functional impairment. The scores for the 3 domains are summed into a total score that ranges from 0 (unimpaired) to 30 (highly impaired). A higher score indicates greater impairment. A negative change score indicates improvement. LOCF method was used for analyses. (NCT01111565)
Timeframe: Week 8 to Week 14

Interventionscore on a scale (Least Squares Mean)
Phase C: Aripiprazole/Escitalopram Combination-1.6
Phase C: Escitalopram Monotherapy-1.8
Phase C: Aripiprazole Monotherapy-0.6

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Number of Participants With Potentially Clinically Significant Physical Examination Findings

(NCT01123707)
Timeframe: Up to 40 weeks

InterventionParticipants (Count of Participants)
Prior Aripiprazole/Escitalopram Combination Therapy0
Prior Escitalopram0
Prior Aripiprazole0
Prior Single-blind Escitalopram0

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Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs (STEAEs), Severe (Grade 3 or Higher) TEAEs, and Discontinuations From the Trial Due to TEAEs

An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it did not necessarily have to have a causal relationship with this treatment. An AE was considered serious if it was fatal; life-threatening; persistently or significantly disabling or incapacitating; required in-patient hospitalization or prolonged hospitalization; a congenital anomaly/birth defect; or other medically significant event that, based upon appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention. TEAE is defined as an adverse event that started after start of study drug treatment. The Common Terminology Criteria for Adverse Events v3.0 (CTCAE) was used to determine the severity wherein Grade 1=mild AE, Grade 2=moderate AE, Grade 3=severe AE, Grade 4=life-threatening or disabling AE, Grade 5=death related to AE. (NCT01123707)
Timeframe: From first dose up to 30 days post last dose (Up to approximately 40 weeks)

,,,
Interventionpercentage of participants (Number)
TEAEsSTEAEsSevere (Grade 3 or Higher) TEAEsDiscontinuations from the Trial due to TEAEs
Prior Aripiprazole75.00.05.613.9
Prior Aripiprazole/Escitalopram Combination Therapy54.52.30.011.4
Prior Escitalopram70.79.84.917.1
Prior Single-blind Escitalopram67.30.02.06.1

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Percentage of Participants With Suicidal Ideation in Each Item as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)

The suicidal ideation compared to Baseline was measured by an increase in suicidal ideation category (1-5 on the C-SSRS) during treatment from the maximum suicidal ideation category at Baseline, or any suicidal ideation during treatment if there is none at Baseline. C-SSRS is used to assess whether participant experienced suicidal ideation (Question 1: wish to be dead; Question 2: non-specific active suicidal thoughts; Question 3: active suicidal ideation with any methods (not plan) without intent to act; Question 4: active suicidal ideation with some intent to act, without specific plan; Question 5: active suicidal ideation with specific plan and intent). A negative change from Baseline indicates improvement. Only those categories and timepoints which have data are reported. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14 and Last Visit (Week 43 or before)

,,,
Interventionpercentage of participants (Number)
Question 1: BaselineQuestion 1: Week 1Question 1: Week 2Question 1: Week 4Question 1: Week 6Question 1: Week 8Question 1: Week 14Question 1: Last Visit (Week 43 or before)Question 2: Week 8Question 2: Week 14Question 2: Last Visit (Week 43 or before)Question 3: Week 14Question 3: Last Visit (Week 43 or before)
Prior Aripiprazole8.32.82.82.82.82.80.05.60.00.02.80.02.8
Prior Aripiprazole/Escitalopram Combination Therapy0.00.00.02.32.30.02.32.30.02.30.02.30.0
Prior Escitalopram12.22.42.44.94.90.00.02.40.00.00.00.00.0
Prior Single-blind Escitalopram4.10.00.00.00.02.00.00.02.00.00.00.00.0

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Number of Participants With Potentially Clinically Significant Vital Sign Abnormalities

Criteria for potentially clinically significant vital sign abnormalities: Heart rate [beats per minute (BPM)]: >120, increase >=15, <50, decrease >=15; systolic blood pressure [millimeter of mercury (mmHg)]: >180, increase >=20, <90, decrease >=20; diastolic blood pressure (mmHg): >105, increase >=15, <50, decrease >=15; orthostatic hypotension: >=20 mmHg decrease in systolic blood pressure and >=25 bpm increase in heart rate from supine to sitting; weight (kg) gain: increase >=7%; or weight loss: decrease >=7%. Only categories with at least 1 participant with event are reported. (NCT01123707)
Timeframe: Up to 40 weeks

,,,
InterventionParticipants (Count of Participants)
Orthostatic Hypotension (mmHg)Weight (kg): Weight Gain >=7%Weight (kg): Weight Loss >=7%
Prior Aripiprazole121
Prior Aripiprazole/Escitalopram Combination Therapy045
Prior Escitalopram002
Prior Single-blind Escitalopram042

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Number of Participants With Potentially Clinically Significant Laboratory Test Abnormalities

The laboratory values were one of the parameters to measure the safety and tolerability of individual participants. Participants with potentially clinically significant lab values in serum chemistry, hematology, urinalyses and prolactin tests that were identified based on pre-defined criteria were reported. Any value outside the normal range was flagged for the attention of the investigator who assessed whether or not a flagged value is of clinical significance. The categories with at least one participants with abnormal lab value as assessed by the Investigator are reported. (NCT01123707)
Timeframe: Up to 40 weeks

,,,
InterventionParticipants (Count of Participants)
Alanine Aminotransferase [Serum Glutamic Pyruvic Transaminase (SGPT)] [unit(U)/L]: >=3×ULNAspartate Aminotransferase [Serum Glutamic Oxaloacetic Transaminase (SGOT)] (U/L): >=3×ULNBilirubin, Total [mg/deciliter(dL)]: ≥2.0Cholesterol, Total, Fasting (mg/dL): ≥240Creatine phosphokinase (CPK), Total (U/L): ≥3 x ULNHigh-density Lipoprotein (HDL) Cholesterol, Fasting (mg/dL): ≤30Low-density Lipoprotein (LDL) Cholesterol, Fasting (mg/dL): ≥160Triglycerides, Fasting (mg/dL): Men ≥160; Women ≥120Urea Nitrogen (mg/dL); >= 30 mg/dLUric Acid (mg/dL): Men ≥10.5; Women ≥8.5Eosinophils (%): ≥10Hematocrit (%): Female ≤32%; Male: ≤37% or 3 point decrease from baselineHemoglobin (g/dL): Men ≤11.5; Women ≤9.5Prolactin [nanograms (ng)/mL]: >1 ULN
Prior Aripiprazole000502414100111
Prior Aripiprazole/Escitalopram Combination Therapy0001000624000011
Prior Escitalopram111910516001101
Prior Single-blind Escitalopram000811825010000

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Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score

The SAS is a rating scale used to measure extrapyramidal symptoms (EPS). The SAS is a 10-item scale, with each item rated from 1 to 5, with 1 being normal and 5 being the worst. The SAS total score is the sum of ratings for all 10 items, with possible total scores from 10 to 50. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

,,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 4Change from Baseline at Week 8Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at Week 32Change from Baseline at End of Study Visit (Week 43 or before)
Prior Aripiprazole/Escitalopram Combination Therapy10.10.0-0.10.00.00.00.1
Prior Escitalopram10.00.30.20.00.00.00.3
Prior Single-blind Escitalopram10.10.1-0.0-0.3-0.3-0.7-0.0

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Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score

The SAS is a rating scale used to measure extrapyramidal symptoms (EPS). The SAS is a 10-item scale, with each item rated from 1 to 5, with 1 being normal and 5 being the worst. The SAS total score is the sum of ratings for all 10 items, with possible total scores from 10 to 50. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 4Change from Baseline at Week 8Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at End of Study Visit (Week 43 or before)
Prior Aripiprazole10.30.0-0.1-0.30.00.1

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Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Total Score

The SDS is a self-rated instrument used to measure the effect of the participant's symptoms on work/school, social life, and family/home responsibilities. For each of the three items, scores range from 0 through 10. The number most representative of how much each area was disrupted by symptoms was marked along the line from 0= not at all, to 10= extremely. For the work/school item, no response was to be entered if the participant did not work or go to school for reasons unrelated to the disorder and a response therefore not being applicable. The SDS Mean Score of 0 to 10 was calculated as an average of the three item scores. All three item scores needed to be available with the exception of the work/school item score when this item was not applicable. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline, Weeks 8, 26 and End of the study visit (Week 43 or before)

,,,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 8Change from Baseline at Week 26Change from Baseline at End of Study visit (Week 43 or before)
Prior Aripiprazole5.1-2.0-2.6-1.6
Prior Aripiprazole/Escitalopram Combination Therapy4.6-1.1-1.9-0.6
Prior Escitalopram4.3-0.81.7-0.5
Prior Single-blind Escitalopram3.8-1.4-0.7-1.6

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Mean Change From Baseline in Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF) Overall General Subscore

The Q-LES-Q-SF is a self-report measure designed to enable investigators to easily obtain sensitive measures of the degree of enjoyment and satisfaction experienced by participants in various areas of daily functioning with the help of 14 items of total 16 items of the scale. The overall general subscore is obtained using 14 items of the scale. Each item is scored on a 5-point scale, with 1= Very Poor; 2=Poor; 3=Fair; 4=Good; 5=Very Good. The raw scores are computed to an overall general subscore of 0 to 100 where lower scores indicate less enjoyment or satisfaction with the activity. A positive change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline, Week 8, 26 and End of the study visit (Week 43 or before)

,,,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 8Change from Baseline at Week 26Change from Baseline at End of Study visit (Week 43 or before)
Prior Aripiprazole47.96.26.24.6
Prior Aripiprazole/Escitalopram Combination Therapy49.40.80.81.0
Prior Escitalopram50.23.6-0.55.0
Prior Single-blind Escitalopram52.29.54.310.0

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Mean Change From Baseline in Patient Global Impression - Severity of Depression Scale (PGI-S) Score

The severity of illness was rated using a 7-point PGI-S. PGI-S scores range from 1 to 7, where 1=not depressed at all, 2=only occasionally depressed to a mild degree, 3=mildly depressed half the time, 4=moderately depressed most of the time, 5=moderately depressed almost all of the time, 6=severely depressed all the time, 7=extremely depressed all the time. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

,,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 1Change from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8Change from Baseline at Week 14Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at Week 32Change from Baseline at End of Study Visit (Week 43 or before)
Prior Aripiprazole/Escitalopram Combination Therapy2.80.1-0.20.0-0.1-0.2-0.1-0.40.00.0-0.1
Prior Escitalopram3.1-0.2-0.4-0.5-0.4-0.4-0.2-0.30.0-1.0-0.3
Prior Single-blind Escitalopram3.2-0.6-1.0-0.9-1.1-0.9-0.9-1.3-1.00.0-0.9

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Mean Change From Baseline in Patient Global Impression - Severity of Depression Scale (PGI-S) Score

The severity of illness was rated using a 7-point PGI-S. PGI-S scores range from 1 to 7, where 1=not depressed at all, 2=only occasionally depressed to a mild degree, 3=mildly depressed half the time, 4=moderately depressed most of the time, 5=moderately depressed almost all of the time, 6=severely depressed all the time, 7=extremely depressed all the time. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 1Change from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8Change from Baseline at Week 14Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at End of Study Visit (Week 43 or before)
Prior Aripiprazole3.3-0.2-0.4-0.2-0.4-0.3-0.8-1.0-0.6-0.3

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Mean Change From Baseline in Massachusetts General Hospital Cognitive and Physical Functioning Questionnaire (CPFQ) Total Score

The CPFQ is a brief self-rated scale developed to measure cognitive and executive dysfunction in mood and anxiety disorders. It consists of 7 items. The CPFQ total score ranges from 7 to 42, with higher score representing less satisfaction in cognitive and physical functioning. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline, Weeks 8, 26 and End of the study visit (Week 43 or before)

,,,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 8Change from Baseline at Week 26Change from Baseline at End of Study Visit (Week 43 or before)
Prior Aripiprazole24.4-2.2-2.2-2.6
Prior Aripiprazole/Escitalopram Combination Therapy23.0-1.3-3.8-1.0
Prior Escitalopram22.1-1.82.0-0.2
Prior Single-blind Escitalopram22.0-4.8-2.5-3.5

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Mean Change From Baseline in Laboratory Test Results: Prolactin

Prolactin is a hormone released by the pituitary gland. The prolactin test measures the amount of prolactin in the blood. Prolactin is responsible for the breast growth and milk production during pregnancy and after birth. The normal prolactin levels range from 20 to 25 ng/mL in males and females and 80 to 400 ng/mL in pregnant women. A negative mean change from Baseline indicates reduction in the prolactin levels. (NCT01123707)
Timeframe: Baseline, Weeks 8, 26, and End of the study visit (Week 43 or before)

,,
Interventionng/mL (Mean)
Mean Change from Baseline at Week 8Mean Change from Baseline at Week 26Mean Change from Baseline at Week Last Visit (Week 43 or before)
Prior Aripiprazole/Escitalopram Combination Therapy0.52-0.790.37
Prior Escitalopram0.31-2.751.33
Prior Single-blind Escitalopram-1.10-0.75-0.49

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Mean Change From Baseline in Laboratory Test Results: Prolactin

Prolactin is a hormone released by the pituitary gland. The prolactin test measures the amount of prolactin in the blood. Prolactin is responsible for the breast growth and milk production during pregnancy and after birth. The normal prolactin levels range from 20 to 25 ng/mL in males and females and 80 to 400 ng/mL in pregnant women. A negative mean change from Baseline indicates reduction in the prolactin levels. (NCT01123707)
Timeframe: Baseline, Weeks 8, 26, and End of the study visit (Week 43 or before)

Interventionng/mL (Mean)
Mean Change from Baseline at Week 8Mean Change from Baseline at Week Last Visit (Week 43 or before)
Prior Aripiprazole0.620.30

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Mean Change From Baseline in Laboratory Test Results: Hemoglobin A1c (HbA1c)

The HbA1c is also known as glycosylated hemoglobin. It is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound. The mean change in the value of HbA1c was analyzed relative to Baseline. The HbA1c of <6.0% signifies the normal blood glucose level. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline, Week 8, and End of the study visit (Week 43 or before)

Interventionpercentage of HbA1c (Mean)
Mean Change from Baseline at Week 8Mean Change from Baseline at Last Visit (Week 43 or before)
Prior Escitalopram0.300.30

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Mean Change From Baseline in Laboratory Test Results: Hemoglobin A1c (HbA1c)

The HbA1c is also known as glycosylated hemoglobin. It is the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound. The mean change in the value of HbA1c was analyzed relative to Baseline. The HbA1c of <6.0% signifies the normal blood glucose level. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline, Week 8, and End of the study visit (Week 43 or before)

Interventionpercentage of HbA1c (Mean)
Mean Change from Baseline at Last Visit (Week 43 or before)
Prior Aripiprazole/Escitalopram Combination Therapy-0.30

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Mean Change From Baseline in Each Item as Measured by Massachusetts General Hospital Sexual Functioning Inventory (MGH SFI) Subscale Score

The MGH SFI is a measure of a participant's self-reported sexual functioning. The MGH SFI included 5 questions at the baseline assessment, each addressing experiences over the last month: Question a) interest in sex, Question b) ability to get sexually aroused, Question c) ability to achieve orgasm, Question d) ability to get and maintain an erection, and Question e) overall sexual satisfaction. The MGH SFI at post-baseline visits included one additional question: Question f) overall improvement since the last medication change. Each question/item is rated from 1 through 6. For questions a) through e), a score of 1 indicates 'greater than normal', and 6 'totally absent'. For question f), a score of 1 indicates 'very much improved', and 6 'much worse'. All question scores are analyzed separately. No total or mean score is derived. Each subscale score ranges from 0 to 6, higher scores indicates worsening. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline, Weeks 8, 26 and End of the study visit (Week 43 or before)

,,,
Interventionscore on a scale (Mean)
Question a: BaselineQuestion a: Change from Baseline at Week 8Question a: Change from Baseline at Week 26Question a: Change from Baseline at End of Study Visit (Week 43 or before)Question b: BaselineQuestion b: Change from Baseline at Week 8Question b: Change from Baseline at Week 26Question b: Change from Baseline at End of Study Visit (Week 43 or before)Question c: BaselineQuestion c: Change from Baseline at Week 8Question c: Change from Baseline at Week 26Question c: Change from Baseline at End of Study Visit (Week 43 or before)Question d: BaselineQuestion d: Change from Baseline at Week 8Question d: Change from Baseline at Week 26Question d: Change from Baseline at End of Study Visit (Week 43 or before)Question e: BaselineQuestion e: Change from Baseline at Week 8Question e: Change from Baseline at Week 26Question e: Change from Baseline at End of Study Visit (Week 43 or before)Question f: BaselineQuestion f: Change from Baseline at Week 8Question f: Change from Baseline at Week 26Question f: Change from Baseline at End of Study Visit (Week 43 or before)
Prior Aripiprazole4.4-0.4-0.4-0.44.1-0.10.0-0.24.1-0.1-0.20.03.6-0.40.00.14.4-0.3-0.4-0.33.40.20.4-0.0
Prior Aripiprazole/Escitalopram Combination Therapy4.2-0.1-0.2-0.13.90.00.20.14.0-0.1-0.2-0.02.50.00.00.14.2-0.1-0.4-0.13.30.1-1.0-0.0
Prior Escitalopram3.8-0.40.0-0.33.7-0.20.0-0.33.8-0.30.0-0.43.00.00.50.03.9-0.30.5-0.33.5-0.30.0-0.2
Prior Single-blind Escitalopram3.6-0.30.0-0.43.5-0.3-0.2-0.33.5-0.2-0.2-0.12.9-0.20.0-0.13.7-0.20.0-0.33.6-0.7-0.8-0.6

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Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score

The severity of illness was rated using a 7-point CGI-S. CGI-S scores range from 1 to 7, where 1=normal, not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill participants. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

,,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 1Change from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8Change from Baseline at Week 14Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at Week 32Change from Baseline at End of the Study Visit (Week 43 or before)
Prior Aripiprazole/Escitalopram Combination Therapy3.1-0.0-0.3-0.1-0.3-0.3-0.3-0.6-0.8-1.0-0.2
Prior Escitalopram3.4-0.2-0.3-0.5-0.5-0.5-0.6-0.30.0-2.0-0.6
Prior Single-blind Escitalopram3.2-0.4-0.9-0.9-0.9-0.7-0.7-0.9-1.3-2.0-0.9

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Mean Change From Baseline in Clinical Global Impression - Severity of Illness Scale (CGI-S) Score

The severity of illness was rated using a 7-point CGI-S. CGI-S scores range from 1 to 7, where 1=normal, not at all ill, 2=borderline mentally ill, 3=mildly ill, 4=moderately ill, 5=markedly ill, 6=severely ill, 7=among the most extremely ill participants. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 1Change from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8Change from Baseline at Week 14Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at End of the Study Visit (Week 43 or before)
Prior Aripiprazole3.4-0.2-0.4-0.6-0.5-0.7-1.0-1.2-1.0-0.7

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Mean Change From Baseline in Body Weight

(NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

Interventionkg (Mean)
BaselineChange from Baseline at Week 1Change from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8Change from Baseline at Week 14Change from Baseline at Week 20Change from Baseline at Last Visit (Week 43 or before)
Prior Aripiprazole87.00.10.20.40.30.40.70.40.1

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Mean Change From Baseline in Body Weight

(NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

Interventionkg (Mean)
BaselineChange from Baseline at Week 1Change from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8Change from Baseline at Week 14Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at Week 32Change from Baseline at Last Visit (Week 43 or before)
Prior Escitalopram88.30.10.20.40.1-0.5-0.92.01.4-3.60.1

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Mean Change From Baseline in Body Weight

(NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

,
Interventionkg (Mean)
BaselineChange from Baseline at Week 1Change from Baseline at Week 2Change from Baseline at Week 4Change from Baseline at Week 6Change from Baseline at Week 8Change from Baseline at Week 14Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at Last Visit (Week 43 or before)
Prior Aripiprazole/Escitalopram Combination Therapy93.00.00.50.30.3-0.02.03.85.7-0.2
Prior Single-blind Escitalopram84.70.10.40.20.30.20.61.43.31.0

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Mean Change From Baseline in Body Mass Index (BMI)

BMI= weight(kg)/[height(m)^2]. (NCT01123707)
Timeframe: Baseline, Week 26 and End of the study visit (Week 43 or before)

,,
Interventionkg/m^2 (Mean)
BaselineChange from Baseline at Week 26Change from Baseline at Last Visit (Week 43 or before)
Prior Aripiprazole/Escitalopram Combination Therapy33.42.30.0
Prior Escitalopram30.90.4-0.1
Prior Single-blind Escitalopram30.71.20.4

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Mean Change From Baseline in Body Mass Index (BMI)

BMI= weight(kg)/[height(m)^2]. (NCT01123707)
Timeframe: Baseline, Week 26 and End of the study visit (Week 43 or before)

Interventionkg/m^2 (Mean)
BaselineChange from Baseline at Last Visit (Week 43 or before)
Prior Aripiprazole31.1-0.1

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Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment of Akathisia (Item 4) Score

The BARS is used to assess the presence and severity of akathisia. This scale consists of 4 items. Only item 4, the 'Global Clinical Assessment of Akathisia', was evaluated for this outcome measure. This item is rated on a 6-point scale, with 0 being best (absent) and 5 being worst (severe akathisia). A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

,,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 4Change from Baseline at Week 8Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at Week 32Change from Baseline at End of Study Visit (Week 43 or before)
Prior Aripiprazole/Escitalopram Combination Therapy0.20.1-0.1-0.1-0.20.0-0.0
Prior Escitalopram0.10.30.3-0.2-0.5-1.00.3
Prior Single-blind Escitalopram0.10.2-0.0-0.30.0-0.30.0

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Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score

The AIMS is a 12-item scale. The first 10 -items are rated from 0 to 4 (0=best, 4=worst). An item score of 0, depending on the item, either means: no abnormal involuntary movement (AIM), or no incapacitation due to AIM, or no awareness of AIM. An item score of 4 either means: severe AIM, or severe incapacitation due to AIM, or being aware of, and severe distress caused by AIM. Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28, where a higher score indicates worst outcome. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

,,
Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 4Change from Baseline at Week 8Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at Week 32Change from Baseline at End of Study Visit (Week 43 or before)
Prior Aripiprazole/Escitalopram Combination Therapy0.1-0.1-0.10.00.00.0-0.0
Prior Escitalopram0.0-0.00.00.00.00.0-0.0
Prior Single-blind Escitalopram0.10.2-0.1-0.20.00.0-0.0

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Mean Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Clinical Assessment of Akathisia (Item 4) Score

The BARS is used to assess the presence and severity of akathisia. This scale consists of 4 items. Only item 4, the 'Global Clinical Assessment of Akathisia', was evaluated for this outcome measure. This item is rated on a 6-point scale, with 0 being best (absent) and 5 being worst (severe akathisia). A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 4Change from Baseline at Week 8Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at End of Study Visit (Week 43 or before)
Prior Aripiprazole0.40.0-0.1-0.40.0-0.1

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Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Total Score

The AIMS is a 12-item scale. The first 10 -items are rated from 0 to 4 (0=best, 4=worst). An item score of 0, depending on the item, either means: no abnormal involuntary movement (AIM), or no incapacitation due to AIM, or no awareness of AIM. An item score of 4 either means: severe AIM, or severe incapacitation due to AIM, or being aware of, and severe distress caused by AIM. Items 11 and 12, related to dental status, have dichotomous responses, 0=no and 1=yes. The AIMS Total Score is the sum of the ratings for the first seven items. The possible total scores are from 0 to 28, where a higher score indicates worst outcome. A negative mean change from Baseline indicates improvement. (NCT01123707)
Timeframe: Baseline; Weeks 1, 2, 4, 6, 8, 14, 20, 26, 32 and End of the study visit (Week 43 or before)

Interventionscore on a scale (Mean)
BaselineChange from Baseline at Week 4Change from Baseline at Week 8Change from Baseline at Week 20Change from Baseline at Week 26Change from Baseline at End of Study Visit (Week 43 or before)
Prior Aripiprazole0.10.00.00.00.0-0.0

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Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Abnormalities

Incidence of clinically relevant abnormal ECG values were reported as change from Baseline in heart rate (Tachycardia - ≥15 beats per minute (bpm), Bradycardia ≤15 bpm; Rhythm (Sinus tachycardia ≥15 bpm increase, Sinus bradycardia decrease of ≥15 bpm from Baseline); Presence of - supraventricular premature beat; ventricular premature beat; supraventricular tachycardia; ventricular tachycardia; atrial fibrillation and flutter. Conduction - Presence of primary, secondary or tertiary atrioventricular block, left bundle-branch block, right bundle-branch block, pre-excitation syndrome, other intraventricular conduction blocked QRS ≥0.12 second increase of ≥0.02 second. Acute, subacute or old Infarction, Presence of myocardial ischemia, symmetrical T-wave inversion. Increase in QTc - QTc ≥450 msec ≥10% increase. Any clinically significant change from Baseline assessed by the Investigator are reported. Only categories with at least 1 participant with event are reported. (NCT01123707)
Timeframe: Up to 40 weeks

,,,
InterventionParticipants (Count of Participants)
Bradycardia: Decrease of ≥15 bpmSinus Bradycardia: Decrease of ≥15 bpmSupraventricular Premature Beat: Not Present to PresentVentricular Premature Beat: Not Present to Present1° Atrioventricular Block: Increase of ≥0.05 secondRight Bundle-branch Block: Not Present to PresentMyocardial Ischemia: Not Present to PresentSymmetrical T-wave Inversion: Not Present to PresentQTcBQTcFQTcN
Prior Aripiprazole00110000221
Prior Aripiprazole/Escitalopram Combination Therapy11100113100
Prior Escitalopram00011001111
Prior Single-blind Escitalopram00000100010

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Patients With Any Treatment Emergent Adverse Events (TEAEs)

The number of patients who experienced one or more TEAE during the 24-week open-label treatment period or the 2-week down-taper period, (NCT01198795)
Timeframe: From Baseline (Week 0) to Week 26

Interventionparticipants (Number)
Escitalopram89

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Change in Dim Light Melatonin Onset

"The Dim Light Melatonin Onset (DLMO) is the time of the onset of melatonin secretion under dim light conditions using the equivalent thresholds of 10 pg/ml in plasma and 3 pg/ml in saliva. It is a marker of biological time. Data are provided in decimal and military time (e.g., 9:30 pm equals 21.50).~This measure is used to determine if there was a change in the time of the dim light melatonin onset (DLMO) before treatment with escitalopram (at Study Visit 3) and after treatment with escitalopram (at Study Visit 11)." (NCT01214044)
Timeframe: 8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)

Interventiondecimal military time (hours) (Mean)
Baseline DLMOPost-escitalopram DLMO
Study Drug21.1720.77

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Change in Phase Angle Difference (PAD)

The PAD is the time interval (number of hours) between the Dim Light Melatonin Onset (DLMO) and the average midpoint of sleep during the prior week. Larger PADs indicate a longer time interval between the DLMO and midpoint of sleep. A negative change in PAD value indicates a shortening of the time interval from Study Visit 3 to Study Visit 11. (NCT01214044)
Timeframe: 8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)

Interventionhours (Mean)
Study Drug-0.6

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Change in Beck Depression Inventory II (BDI-II) Scores

The BDI-II is the total score on the 21-question Beck Depression Inventory II questionnaire. Scores range from 0 to 63 with higher scores indicating worse symptoms of depression. (NCT01214044)
Timeframe: 8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)

Interventionunits on scale (scores) (Mean)
Study Drug-3.3

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Change in Hamilton Depression Rating Scale (HAM-D) Scores

The HAM-D is the total score on the 21-question Hamilton Depression Rating Scale. Scores range from 0 to 53 with higher scores indicating worse symptoms of depression. (NCT01214044)
Timeframe: 8 Weeks: Study Visit 3 (after 1 week of placebo) to study Visit 11 (after 8 weeks of escitalopram)

Interventionunits on scale (scores) (Mean)
Study Drug-2.3

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Hamilton Depression Scale

Measure of severity of depression -total score of Hamilton Depression Scale ranges from 0 (no depression) to 60 (worst depression possible) (NCT01244724)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Lexapro13.3

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High Frequency Heart Rate Variability

Heart rate variability is the standard deviation of successive R-to-R intervals, or variability in time between successive heart beats. Spectral power in the high frequency (HF: 0.15-0.5 Hz) band reflects parasympathetic input, or cardiac vagal function. A natural log (ln) transformation was applied to heart rate variability data to derive the outcome measure. (NCT01271244)
Timeframe: 12 Weeks

Interventionln(msec) (Mean)
Pre-treatmentPost-treatment
PTSD Depression Group6.315.48

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QT Interval Variability

QT variability index (QTvi) is a measure of QT variability normalized to heart rate variability. Increased QTvi has been associated with increased sympathetic activity. QTvi was calculated using Berger's formula as the log ratio of QT variability normalized by the squared mean QT interval divided by heart rate variability normalized by the squared mean heart rate. QTvi is normally expressed as a negative value, and a less negative QTvi may reflect increased QT variability or reduced heart rate variability. (NCT01271244)
Timeframe: 12 weeks

Interventionlog ratio (Mean)
Pre-treatmentPost-treatment
PTSD Depression Group-1.82-1.32

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Early and Sustained (Antidepressant) Response (ESR) Rate

Early and Sustained Response (ESR) is defined as a MADRS total score reduction from Baseline of 50% or more and a MADRS total score ≤16 at Week 2, Week 3, Week 4, and Week 6. (NCT01312922)
Timeframe: From (end of) Week 2 visit to (end of) Week 6 visit

InterventionParticipants (Count of Participants)
PNB0117
Citalopram17
Pipamperone17

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Hamilton Rating Scale for Depression (HRSD)

The patient is rated by a clinician on 17 items that measure depressive symptom severity. The total score is calculated by summing the responses across all items. Lower scores (closer to 0) indicate the absence of depressive symptoms, while higher scores indicate the presence of depressive symptoms. Eight items are scored on a 5-point scale, ranging from 0 = not present to 4 = severe. Nine are scored from 0-2 (0 = not present; 2 = severe). The scale range of scores is 0-52. (NCT01324700)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
High Severity: Escitalopram10.08
High Severity: Placebo14.38
Low Severity: Escitalopram10.39
Low Severity: Placebo9.31

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Asthma Control Questionnaire (ACQ)

The ACQ has 7 questions (the top scoring 5 symptoms, FEV1% pred. and daily rescue bronchodilator use). Patients are asked to recall how their asthma has been during the previous week and to respond to the symptom and bronchodilator use questions on a 7-point scale (0=no impairment, 6= maximum impairment). Clinic staff score the FEV1% predicted on a 7-point scale. The questions are equally weighted and the ACQ score is the mean of the 7 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). (NCT01324700)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
High Severity: Escitalopram1.15
High Severity: Placebo1.63
Low Severity: Escitalopram1.39
Low Severity: Placebo1.23

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Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score

"The IDS-SR was a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of MDD. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the best rating and 3 being the worst rating. The IDS-SR Total Score is the sum of ratings of 28 item scores. The possible IDS-SR Total Score ranges from 0 (best) to 84 (worst).~Under item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. If the number of items recorded is at least 23 and at most 27, the IDS-SR Total Score will be the mean of the recorded items multiplied by 28 and then rounded to the first decimal place." (NCT01360866)
Timeframe: From screening to week 52/early termination

Interventionunits on a scale (Mean)
Prior Placebo-5.25
Prior Brexpiprazole-4.76
Prior ADT-3.94
Prior Seroquel-7.44

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Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score

"The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on regular life responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains with scores from 0 = not at all, to 10 = extremely.~Scores of 5 and above were associated with significant functional impairment." (NCT01360866)
Timeframe: From screening to week 52/early termination

Interventionunits on a scale (Mean)
Prior Placebo-0.80
Prior Brexpiprazole-0.70
Prior ADT-0.40
Prior Seroquel-1.00

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Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score

The efficacy of trial treatment was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant's condition at screening. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse. (NCT01360866)
Timeframe: From screening to week 52/early termination

Interventionunits on a scale (Mean)
Prior Placebo2.60
Prior Brexpiprazole2.63
Prior ADT2.63
Prior Seroquel2.40

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Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score

"The severity of illness for each participant was rated using the CGI-S . On the basis of the investigator answer to the question: Considering your total clinical experience with this particular population, how mentally ill was the participant at that time? Response choices included: 0 = not assessed; 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = among the most extremely ill participants." (NCT01360866)
Timeframe: From screening to week 52/early termination

Interventionunits on a scale (Mean)
Prior Placebo-0.77
Prior Brexpiprazole-0.63
Prior ADT-0.48
Prior Seroquel-0.93

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Adverse Events (AEs) - All Participants

To assess the frequency and severity of AEs as the variables of safety and tolerability of brexpiprazole. (NCT01360866)
Timeframe: From screening to week 52/early termination

,,,
InterventionParticipants (Count of Participants)
Participants with adverse eventsParticipants with treatment emergent AE (TEAE)Participants with serious TEAEParticipants with severe TEAEPartcipants discontinued due to AEs
Prior ADT116511633399134
Prior Brexpiprazole511510236458
Prior Placebo400399144855
Prior Seroquel5151146

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Change From Baseline in the Changes in Sexual Functioning Questionnaire Short-Form (CSFQ-14) Total Score at Week 8

The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A positive change from Baseline indicates that symptoms have improved. The primary analysis was based on a mixed model for repeated measurements (MMRM) analysis of covariance with treatment, center, week, treatment-by-week interaction as fixed effects, Baseline CSFQ-14 total score-by-week as covariate, and a completely unstructured covariance matrix. (NCT01364649)
Timeframe: Baseline, Week 8

Interventionscores on a scale (Least Squares Mean)
Vortioxetine8.8
Escitalopram6.6

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Change From Baseline in the CSFQ-14 Total Score at All Other Time Points Assessed

The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. A positive change from Baseline indicates that symptoms have improved. The primary analysis was based on a mixed model for repeated measurements (MMRM) analysis of covariance with treatment, center, week, treatment-by-week interaction as fixed effects, Baseline CSFQ-14 total score-by-week as covariate, and a completely unstructured covariance matrix. (NCT01364649)
Timeframe: Baseline and Weeks 1, 2, 4 and 6

,
Interventionscores on a scale (Least Squares Mean)
Week 1 (n=213, 206)Week 2 (n=203, 200)Week 4 (n=187, 188)Week 6 (n=175, 176)
Escitalopram2.23.74.86.4
Vortioxetine2.54.97.08.0

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Number of Participants With Shifts in the CSFQ-14 From Abnormal to Normal at Each Week Assessed

The CSFQ-14 is a structured self reported questionnaire designed to measure illness- and medication-related changes in sexual functioning consisting of 14 items that measure sexual functioning as a total score (14 items) and on the subscales of pleasure (1 item), desire/frequency (2 items), desire/interest (3 items), arousal (3 items), and orgasm (3 items), rated on an 5 point scale from 1 to 5 with a total score range from 14 to 70. Higher scores reflect higher sexual functioning. Normal sexual functioning is defined as a CSFQ-14 total score of >41 for women and >47 for men. Abnormal sexual functioning is defined as a CSFQ-14 total score of ≤41 for women and ≤47 for men. All subjects entered the study with abnormal sexual functioning. A shift to normal indicates that symptoms have improved. (NCT01364649)
Timeframe: Baseline and Weeks 1, 2, 4, 6 and 8

,
Interventionnumber of participants (Number)
Week 1 (n=213, 205)Week 2 (n=217, 206)Week 4 (n=217, 206)Week 6 (n=217, 206)Week 8 (n=217, 206)
Escitalopram3663849391
Vortioxetine488193112113

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Mini Mental Status Exam (MMSE)

"This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal).~A score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable." (NCT01368432)
Timeframe: At 12 weeks

Interventionunits on a scale (Mean)
Placebo Group 12 Weeks29.7
Treatment Group 12 Weeks29.0

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Mini Mental Status Exam (MMSE)

"This outcome measure assess the participants Cognitive status. Scores range from 0 ( significantly impaired) -30 ( normal).~A score of 23 or lower is indicative of cognitive impairment. In this study the score was used as a continuous variable." (NCT01368432)
Timeframe: At baseline

Interventionunits on a scale (Mean)
Placebo Group Baseline28.3
Treatment Group Baseline27.1

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Montgomery-Asberg Depression Rating Scale (MADRS)

"This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60.~0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; >34 - severe depression.~In this study the score was used as a continuous variable." (NCT01368432)
Timeframe: MADRS score at 12 weeks

Interventionunits on a scale (Mean)
Placebo Group MADRS 12 Weeks11.2
Treatment Group MADRS 12 Weeks7

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Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline

"This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60.~0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; >34 - severe depression.~In this study the score was used as a continuous variable." (NCT01368432)
Timeframe: MADRS score at baseline

Interventionunits on a scale (Mean)
Placebo Group Baseline29.5
Treatment Group Baseline33.6

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Quality of Life (QWL)

"This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale.~Scores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable." (NCT01368432)
Timeframe: At 12 weeks

Interventionunits on a scale (Mean)
Placebo Group 12 Weeks75.2
Treatment Group 12 Weeks78.7

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Quality of Life (QWL)

"This outcome measure is assessing the participants impression of their quality of life as measured by the QWL scale.~Scores range from 16 ( terrible quality of life ) to 112 (Very delighted). Used as a continuous variable." (NCT01368432)
Timeframe: At baseline

Interventionunits on a scale (Mean)
Placebo Group Baseline62.8
Treatment Group Baseline64.1

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Satisfaction With Life (SWL)

"This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale.~The scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life).~It is used as continuous variable." (NCT01368432)
Timeframe: baseline

Interventionunits on a scale (Mean)
Placebo Group Baseline13.8
Treatment Group Baseline15.6

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Clinical Anxiety Scale (CAS)

"This outcome measure is assessing the participant's anxiety as assessed by the CAS.~The scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable." (NCT01368432)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Placebo Group Baseline9.8
Treatment Group Baseline14.8

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Clinical Global Impression (CGI) - Severity at Baseline

"This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator. Scores range from 1-7~= Normal-not at all ill~= Borderline mentally ill~= Mildly ill~= Moderately ill~= Markedly ill~= Severely ill~= Among the most extremely ill patients." (NCT01368432)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Placebo Group Baseline4.5
Treatment Group Baseline4.8

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Clinical Anxiety Scale (CAS)

"This outcome measure is assessing the participant's anxiety as assessed by the CAS.~The scores range from 0( normal; no anxiety) to 21 ( severe anxiety). It is used as a continuous variable." (NCT01368432)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Placebo Group 12 Weeks6.3
Treatment Group 12 Weeks3.9

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Clinical Global Impression (CGI)- Improvement

"This outcome measure is assessing the participant's overall psychiatric health based upon the CGI score as assessed by the investigator.~The scores range from 1-7~= Very much improved~= Much improved~= Minimally improved~= No change~= Minimally worse~= Much worse~= Very much worse" (NCT01368432)
Timeframe: at 12 weeks

Interventionunits on a scale (Mean)
Placebo Group 12 Weeks2.7
Treatment Group 12 Weeks2.1

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Satisfaction With Life (SWL)

"This outcome measure asses the participants overall satisfaction with life as measured by the SWL scale.~The scores range from 5 ( absolutely no satisfaction ) to 35 ( very satisfied with life).~It is used as continuous variable." (NCT01368432)
Timeframe: 12 weeks

Interventionunits on a scale (Mean)
Placebo Group 12 Weeks21.2
Treatment Group 12 Weeks22.6

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Disability Rating Scale (DRS)

"This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable.~Scores range from 0 (normal) and 29 (extreme vegetative state)." (NCT01368432)
Timeframe: At 12 weeks

Interventionunits on a scale (Mean)
Placebo Group 12 Weeks0.7
Treatment Group 12 Weeks0.6

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Disability Rating Scale (DRS)

"This scale is a measure of impairment, disability and handicap. It is intended to measure accurately general functional changes over the course of recovery and has found to be both valid and reliable.~Scores range from 0 (normal) and 29 (extreme vegetative state)." (NCT01368432)
Timeframe: At baseline

Interventionunits on a scale (Mean)
Placebo Group Baseline1
Treatment Group Baseline1.4

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Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Early Extinction Trials 1 to 4

"Three-way interaction between group (active vs. placebo), CS (+ vs. -), and trials (1 - 4).~CS+ refers to the conditioned stimulus associated with the unconditioned stimulus (electric shock). Higher numbers reflect higher skin conductance response to the CS+ (conditioned stimulus).~CS- refers to the stimulus not associated with the unconditioned stimulus. Higher numbers reflect higher skin conductance response to a CS-.~Square-root transformed skin conductance conditioned response are reported for trials 1 to 4 of the Early Extinction Phase." (NCT01398514)
Timeframe: Day 2 of Fear Conditioning Paradigm (15 to 18 days post medication initiation)

,,,
Interventionmicro-Siemens (square rooted) (Mean)
Trial 1Trial 2Trial 3Trial 4
Active Medication CS-0.7450.4960.5440.374
Active Medication CS+0.8530.6340.5200.361
Placebo CS-0.7990.3860.4380.309
Placebo CS+0.7170.5580.7870.510

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Physiological Reactivity as Measured by Square-root Transformed Skin Conductance Conditioned Response in Acquisition Trials 1 to 5

"Three-way interaction between group (active vs. placebo), CS (+ vs. -), and trials (1 - 5).~CS+ refers to the conditioned stimulus associated with the unconditioned stimulus (electric shock). Higher numbers reflect higher skin conductance response to the CS+ (conditioned stimulus).~CS- refers to the stimulus not associated with the unconditioned stimulus. Higher numbers reflect higher skin conductance response to a CS-.~Square-root transformed skin conductance conditioned response are reported for trials 1 to 5 of the Acquisition Phase." (NCT01398514)
Timeframe: Baseline on Day 1 of Fear Conditioning Paradigm (14 to 17 days post medication initiation)

,,,
Interventionmicro-Siemens (square rooted) (Mean)
Trial 1Trial 2Trial 3Trial 4Trial 5
Active Medication CS-0.6340.4190.2300.2310.281
Active Medication CS+0.5740.8700.6850.6260.543
Placebo CS-0.5320.4280.3310.1810.144
Placebo CS+0.6340.8170.8560.6770.714

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Nocturnal Ingestions

Number of nocturnal ingestions (waking and having something to eat) were reported at each visit. (NCT01401595)
Timeframe: 12 weeks

,
Interventionunits on a scale (Mean)
baseline nocturnal ingestions/weektreatment end nocturnal ingestions/week
Controls0.0NA
Night Eating Syndrome Open Label Escitalopram Treatment5.81.2

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Night Eating Symptoms

"The responses on the Night Eating Symptom Scale (NESS) will be examined over time.~Subjects will complete the NESS at their baseline visit, and at every treatment visit thereafter. The Night Eating Symptom Scale-II (NESS-II) (Lundgren, Allison, Vinai, & Gluck, 2012) is a 14-item questionnaire (possible range of 0-56, with higher scores indicating more severe symptoms) that assesses the presence of NES features over the course of the previous week. The NESS will indicate whether or not escitalopram is having an effect on our participants' night eating symptoms." (NCT01401595)
Timeframe: 12 weeks

,
Interventionunits on a scale (Mean)
Baseline Night Eating Symptom Scaletreatment end night eating symptom scale
ControlsNANA
Night Eating Syndrome Open Label Escitalopram Treatment30.215.2

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Change in Symptoms of NES

Outcome of treatment will be measured by self report questionnaire, the Night Eating Symptom Scale ( higher score indicates worse symptoms). The percentage of calories consumed after dinner was estimated by recall at each treatment visit, as compared to their baseline % of intake after dinner, which was calculated through food diaries. The number of nocturnal ingestions (waking during the night and eating) per week was also recalled at each treatment visit. (NCT01401595)
Timeframe: 12 weeks

,
Interventionpercentage of calories after dinner (Mean)
baseline %calories consumed after dinnertreatment end %calories after dinner
Controls11.8NA
Night Eating Syndrome Open Label Escitalopram Treatment46.117.4

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Change From Baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score at Week 10

The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A negative change score indicates improvement. (NCT01473381)
Timeframe: Baseline to Week 10

InterventionUnits on a scale (Least Squares Mean)
Placebo-14.76
Vilazodone 20 mg/Day-17.33
Vilazodone 40 mg/Day-17.58
Citalopram 40 mg/Day-17.50

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Percentage of Participants With a Montgomery-Åsberg Depression Rating Scale (MADRS) Sustained Response

The MADRS is a clinician-rated scale based on participant interviews. The scale assesses depressive symptomatology that occurred in participants during the week preceding each interview. Participants were rated on 10 items: Apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts. Each item was scored on a 7-point scale from 0 (no symptoms) to 6 (symptoms of maximum severity). The total score was the sum of the scores of the 10 items and ranged from 0 to 60. A higher score indicates more depressive symptomatology. A MADRS sustained response was defined as a MADRS total score ≤ 12 for at least the last 2 visits during the double-blind treatment period (Weeks 1-10). A total MADRS score ≤ 12 corresponds to an average score of 1 per item and is indicative of very low level of depressive symptoms. (NCT01473381)
Timeframe: Baseline to Week 10

InterventionPercentage of participants (Number)
Placebo26.3
Vilazodone 20 mg/Day29.9
Vilazodone 40 mg/Day33.5
Citalopram 40 mg/Day31.1

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Change From Baseline to Week 10 in the Clinical Global Impressions-Severity (CGI-S) Scale Score

"The Clinical Global Impressions-Severity scale is a clinician-rated scale used to rate the severity of the participant's current state of mental illness compared with a patient population with major depressive disorder. In particular, the clinician is asked to respond to the following question: Considering your total clinical experience with this population, how mentally ill is the patient at this time? The patient is rated on the following 7-point scale: 1-normal, not at all ill, 2-borderline ill, 3-mildly ill, 4-moderately ill, 5-markedly ill, 6-severely ill, 7-among the most extremely ill patients. A higher score indicates more mental illness. A negative change score indicates improvement." (NCT01473381)
Timeframe: Baseline to Week 10

InterventionUnits on a scale (Least Squares Mean)
Placebo-1.53
Vilazodone 20 mg/Day-1.88
Vilazodone 40 mg/Day-1.86
Citalopram 40 mg/Day-1.88

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Number of Participants With Cocaine-negative Urines Collected During Treatment Period

Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use. (NCT01535573)
Timeframe: 9 weeks

InterventionParticipants (Count of Participants)
Citalopram Low Dose14
Citalopram High Dose26
Placebo27

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Proportion of Cocaine-positive Urines Per Week

Mean proportion of cocaine-positive urines per week, averaged across 9 weeks, is reported. Urine was collected three times each week over 9 weeks. Missing data is imputed as cocaine use. (NCT01535573)
Timeframe: 9 weeks

Interventionproportion of cocaine urines per week (Mean)
Citalopram Low Dose0.85
Citalopram High Dose0.8
Placebo0.85

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Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test

Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use. (NCT01535573)
Timeframe: 9 weeks

InterventionParticipants (Count of Participants)
Citalopram Low Dose0
Citalopram High Dose4
Placebo2

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Retention as Assessed by Number of Participants Remaining in Treatment

(NCT01535573)
Timeframe: 9 weeks

InterventionParticipants (Count of Participants)
Citalopram Low Dose13
Citalopram High Dose23
Placebo24

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International Cooperative Ataxia Rating Scale (ICARS)

The ICARS is a 19 item rating scale of ataxia with the total score ranging from 0 to 100. A score of 0 means normal and higher scores represent worsened disease. (NCT01716221)
Timeframe: Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 weeks (bupropion), and 20 weeks (citalopram + bupropion)

Interventionunits (Number)
Bupropion & Citalopram39
Bupropion & Placebo30
Placebo & Citalopram47
Placebo & Placebo46
Baseline42

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Hamilton Depression Rating Scale

The Hamilton Depression Rating Scale is a 21 item questionnaire scored each item on a scale of 0 to 3 or 5. The max score is 66. Higher scores indicate worsened depression. All items are summed together to give a total score. A total score of 0-7 is considered normal, while total scores greater than 20 are indicative of moderate or greater depression. (NCT01716221)
Timeframe: Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)

Interventionunits on a scale (Number)
Baseline - Unblinded on Buproprion and Citalopram7
Citalopram (Week 5)10
OFF - Bupropion Placebo + Citalopram Placebo (Week 10)2
Bupropion Only (Week 15)3
Bupropion + Citalopram (Week 20)4

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Comparison of FARS and ICARS

Differences between FARS - ICARS at each treatment interval (NCT01716221)
Timeframe: Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)

Interventionpoints (Number)
Baseline - Unblinded on Buproprion and Citalopram1
Citalopram (Week 5)-6
OFF - Bupropion Placebo + Citalopram Placebo (Week 10)1
Bupropion Only (Week 15)12
Bupropion + Citalopram (Week 20)6

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Friedreich Ataxia Rating Scale (FARS)

A rating scale developed for Friedreich ataxia in evaluation of ataxia. Score range from 0-159 with a score of 0 meaning normal and greater scores indicating worsened disease. (NCT01716221)
Timeframe: Assessements are performed in 5 different states in a single patient: baseline (Bupropion 100mg and Citalopram 20mg - unblinded), then blinded at 5 weeks (citalopram), 10 weeks (placebo), 15 (bupropion), and 20 weeks (citalopram + bupropion)

Interventionpoints (Number)
Baseline - Unblinded on Buproprion and Citalopram43
Citalopram (Week 5)41
OFF - Bupropion Placebo + Citalopram Placebo (Week 10)47
Bupropion Only (Week 15)42
Bupropion + Citalopram (Week 20)45

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Change in Depression Severity (Measured by Hamilton Depression Rating Scale)

Depression severity at baseline and week 12 in participants with MDD vs. controls, measured by score on the Hamilton Depression Rating Scale (HAM-D). This measure is a clinical rating of mood with a score range from 0 to 76. Higher scores indicate greater depression severity. (NCT01728194)
Timeframe: Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)

,
Interventionscore on a scale (Mean)
Baseline Depression SeverityWeek 12 Depression Severity
Control1.241.52
Escitalopram23.4812.44

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Change in Depression Severity (Measured by Montgomery Asberg Depression Rating Scale)

Depression severity at baseline and week 12 in participants with MDD vs. controls, measured by score on the Montgomery Asberg Depression Rating Scale (MADRS). This measure is a clinical rating of mood with a score range from 0 to 60. Higher scores indicate greater depression severity. (NCT01728194)
Timeframe: Baseline (Study Entry / Before Tx) and Week 12 (Following Tx)

,
Interventionscore on a scale (Mean)
Baseline Depression SeverityWeek 12 Depression Severity
Control1.031.08
Escitalopram25.2613.78

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Effects of Acute Tryptophan Depletion on Mood

"We will examine differences in scores on the the HAMD-28 before and after acute tryptophan depletion. Changes in these parameters will be compared between placebo responders and drug responders using unpaired two-tailed t-tests.~The HAMD-28 measures depression severity, and has a minimum value of 0 and a maximum value of 81 units on a scale, where higher scores indicate more severe depression.~A negative change value refers to a decrease in HAM D score." (NCT01787240)
Timeframe: Baseline, Visit 10 (after 9 weeks in study)

Interventionunits on a scale (Mean)
Phase 2 Placebo-6.0
Phase 2 Active-13.0

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Effects of Acute Tryptophan Depletion on Mood

"We will examine differences in scores on the the HAMD-28 before and after acute tryptophan depletion. Changes in these parameters will be compared between placebo responders and drug responders using unpaired two-tailed t-tests.~The HAMD-28 measures depression severity, and has a minimum value of 0 and a maximum value of 81 units on a scale, where higher scores indicate more severe depression.~A negative change value refers to a decrease in HAM D score." (NCT01787240)
Timeframe: Baseline, Visit 5 (4 weeks into study)

Interventionunits on a scale (Mean)
Placebo-6.4
Escitalopram 10mg-8.8

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Feasibility

We will measure the percentage of screened eligible patients who agree to be randomized. Participants were assessed for this Outcome Measure before randomization.This would occur at the first study visit (screening). (NCT01787240)
Timeframe: This would occur at the first study visit (screening).

Interventionpercent of eligible patients (Number)
Eligible Patients95.2

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Change in Hamilton Anxiety Scale (HAM-A) Total Scores From Baseline up to Day 56

"HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5-point scale, ranging from 0 (not present) to 4 (severe). Total score is calculated by adding the scores for each of the 14 items and the score ranges from 0 to 56. The interpretation of total scores are: 0 to 17 is considered to be mild, 18 to 25 mild to moderate, and 26 to 30 moderate to severe and above 30 indicate very severe anxiety. Higher scores indicate worsening." (NCT01870843)
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56

InterventionUnits on a scale (Mean)
BaselineChange at Day 7Change at Day 14Change at Day 28Change at Day 42Change at Day 56
Escitalopram Oxalate25.6-5.6-10.1-12.9-15.1-17.5

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Change in Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) Total Scores From Baseline up to Day 56

QIDS-SR contains 16 question regarding 9 Major depression disorder symptoms (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Each question is rated on a 4-point scale (range, 0 to 3). Total score is the sum of scores calculated by adding scores for each question and the interpretation is as follows: 0-5 (no depression likely); 6-10 (possibly mildly depressed); 11-15 (moderate depression); 16-20 (severe depression); 21-27 (very severe depression). Higher scores represent more severe depression symptoms. (NCT01870843)
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56

InterventionUnits on a scale (Mean)
BaselineChange at Day 7Change at Day 14Change at Day 28Change at Day 42Change at Day 56
Escitalopram Oxalate14.9-2.9-4.7-6.1-7.4-8.6

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Change in Montgomery-Asberg Depression Rating Scale (MADRS) Scores From Baseline up to Day 56

"The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on a 7-point scale and the scores range from 0 = item not present/normal to 6 = severe/continuous presence of the symptoms. Total score is calculated by adding the scores for all the 10 items and it ranges from 0 to 60. The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression." (NCT01870843)
Timeframe: Baseline, Day 7, Day 14, Day 28, Day 42 and Day 56

InterventionUnits on a scale (Mean)
BaselineChange at Day 7Change at Day 14Change at Day 28Change at Day 42Change at Day 56
Escitalopram Oxalate29.1-5.6-10.5-13.6-16.4-19.1

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Change in Quality of Life Enjoyment and Satisfaction Questionnaire, Short Form (Q-LES-Q-SF) From Baseline up to Day 56

"Q-LES-Q-SF is a 14-item questionnaire in which each question is rated on a 5-point scale with scores ranging from 1 = very poor to 5 = very good. The total raw score is calculated by summing up the scores for the 14 items. The raw total score ranges from 14 to 70. The raw total score is transformed into a percentage maximum possible score using the following formula: (raw total score minus minimum score) divided by (maximum possible raw score minus minimum score). The minimum raw score on the Q-LES-Q-SF is 14, and the maximum score is 70. Lower score indicate worsening." (NCT01870843)
Timeframe: Baseline, Day 14, Day 28, Day 42 and Day 56

InterventionUnits on a scale (Mean)
Baseline (n=239)Change at Day 14 (n=219)Change at Day 28 (n=230)Change at Day 42 (n=230)Change at Day 56 (n=230)
Escitalopram Oxalate39.39.615.119.022.5

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Change in Sheehan Disability Scale (SDS) From Baseline up to Day 56

"SDS is a composite of 3 self-rated items designed to measure the extent to which 3 major sectors in the participant's life are impaired by panic, anxiety, phobic, or depressive symptoms. The participant rates the extent to which his or her (1) work, (2) social life or leisure activities, and (3) home life or family responsibilities are impaired by his or her symptoms on a 10-point visual analog scale. To get a total score add up the 3 individual scores and the total score ranges from 0 = unimpaired to 30 = highly impaired. Higher scores indicate worsening." (NCT01870843)
Timeframe: Baseline, Day 14, Day 28, Day 42, and Day 56

InterventionUnits on a scale (Mean)
Baseline (n=234)Change at Day 14 (n=216)Change at Day 28 (n=225)Change at Day 42 (n=225)Change at Day 56 (n=225)
Escitalopram Oxalate17.4-4.6-7.0-8.3-10.1

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Depression Response Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56

"The MADRS is a 10 item scale designed to measure depression severity. Each item is scored on a 7 point scale and the scores range from 0 = item not present/normal to 6 = severe/continuous presence of the symptoms. Total score is calculated by adding the scores for all the 10 items and ranges from 0 to 60. The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; 35 to 60= severe depression data was obtained by Last observation carried forward (LOCF) method." (NCT01870843)
Timeframe: Day 7, Day 14, Day 28, Day 42 and Day 56

InterventionPercentage of participants (Number)
Day 7 (n=235)Day 14 (n=240)Day 28 (n=240)Day 42 (n=240)Day 56 (n=240)
Escitalopram Oxalate7.225.046.761.774.2

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Remission Rate Based on Hamilton Anxiety Scale (HAM-A) up to Day 56

"HAM-A is a rating scale developed to quantify the severity of anxiety symptomatology. It consists of 14 items, each defined by a series of symptoms. Each item is rated on a 5 point scale, ranging from 0 (not present) to 4 (severe). Total score is calculated by adding the scores for each of the 14 items and the score ranges from 0 to 56. The interpretation of total scores are: 0 to 17 is considered to be mild, 18 to 25 mild to moderate, and 26 to 30 moderate to severe and 31 to 56 indicate very severe anxiety. Higher scores indicate worsening data was obtained by Last observation carried forward (LOCF) method." (NCT01870843)
Timeframe: Day 7, Day 14, Day 28, Day 42 and Day 56

InterventionPercentage of participants (Number)
Day 7 (n=235)Day 14 (n=240)Day 28 (n=240)Day 42 (n=240)Day 56 (n=240)
Escitalopram Oxalate4.315.831.743.861.3

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Remission Rate Based on Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) up to Day 56

QIDS-SR contains 16 question regarding 9 Major depression disorder symptoms (sleep, weight, psychomotor changes, depressed mood, decreased interest, fatigue, guilt, concentration, and suicidal ideation). Each question is rated on a 4-point scale (range, 0 to 3). Total score is the sum of scores calculated by adding scores for each question and the interpretation is as follows: 0-5 (no depression likely); 6-10 (possibly mildly depressed); 11-15 (moderate depression); 16-20 (severe depression); 21-27 (very severe depression). Higher scores represent more severe depression symptoms data was obtained by Last observation carried forward (LOCF) method. (NCT01870843)
Timeframe: Day 7, Day 14, Day 28, Day 42 and Day 56

InterventionPercentage of participants (Number)
Day 7 (n=228)Day 14 (n=237)Day 28 (n=237)Day 42 (n=237)Day 56 (n=237)
Escitalopram Oxalate7.515.227.042.651.5

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Remission Rate Based on Montgomery-Asberg Depression Rating Scale (MADRS) up to Day 56

"Remission rate is defined as percentage of participants with MADRS total scores less than or equal to 10 at the endpoint (at week 8). The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on 7-point scale, from 0 = not present/normal to 6 = severe/continuous presence of the symptoms and the total score (addition of all 10-items) ranges from 0 to 60. The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression." (NCT01870843)
Timeframe: Day 7, Day 14, Day 28, Day 42 and Day 56

InterventionPercentage of participants (Number)
Day 7 (n=235)Day 14 (n=240)Day 28 (n=240)Day 42 (n=240)Day 56 (n=240)
Escitalopram Oxalate3.416.327.543.361.7

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Treatment Improvement Rate at the End of Week 1 and Week 2

"Onset of effect is defined as the reduction rate greater than or equal to 20 percent change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total scores. The MADRS is a 10-item scale designed to measure depression severity. Each item is scored on 7-point scale, from 0 = not present/normal to 6 = severe/continuous presence of the symptoms and the total score (addition of all 10-items) ranges from 0 to 60. The interpretations of the scores are: 0 to 6= normal/symptom absent; 7 to 19= mild depression; 20 to 34= moderate depression; more than 34= severe depression." (NCT01870843)
Timeframe: Week 1 and Week 2

InterventionParticipants (Number)
Week 1 (n=235)Week 2 (n=240)
Escitalopram Oxalate98174

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Change in 24-item HAMD

Change in 24-item Hamilton Rating Scale for Depression (HAMD) scores from baseline to Week 48: HAMD measures depression severity based on a series of 24 items items. The range of HAMD total score is 0-74; 0 indicates no depressive symptoms and a maximum HAMD score is a 74, where the greater the score indicates more significant psychopathology. In this study, moderate to severe depression is considered a HAMD-24 greater than 14. (NCT01876823)
Timeframe: Baseline, Week 48

Interventionscores on a scale (Mean)
Es-citalopram and Memantine Treatment-15.2

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Change in Selective Reminding Test - Delayed Recall (SRT-DR)

Change in Selective Reminding Test-Delayed Recall scores from baseline to Week 48: SRT Delay is administered 15 minutes after the immediate recall portion. Patients are asked to remember as many of the words as they can from the 6 trials. Maximum raw score is a 12 for free recall. If a patient is unable to recall a word, they are given a chance to recognize it among three incorrect word choices. Maximum raw score for recognition is 12. The greater the score on the delayed recall portion, the better the patient does on the assessment. (NCT01876823)
Timeframe: Baseline, Week 48

Interventionunits on a scale (Mean)
Es-citalopram and Memantine Treatment1.2

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Change in Selective Reminding Test - Total Immediate Recall (SRT-IR)

Change in Selective Reminding Test-Total Immediate Recall (SRT-IR) scores from baseline to Week 48: Measures word recall (maximum 12 words per trial, across 6 trials). Maximum total recall score across 6 trials is 72; minimum recall is 0 across 6 trials. The higher the raw score, the better the patient did at recalling the target words. The unit of measure is the raw score, or the sum of the number of words recalled across all 6 trials. (NCT01876823)
Timeframe: baseline, 48 weeks

Interventionunits on a scale (Mean)
Es-citalopram and Memantine Treatment7.5

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Change in Trails A

Change in Trails A scores from baseline to Week 48: Measures attention and executive function. It asks patients to connect numbers from 1-25 in numerical order as fast as they can. Patients are timed; the longer it takes for the patient to connect the numbers, the worse their score. Unit of measure is in seconds. The amount of errors that the patient makes during trails is also recorded. (NCT01876823)
Timeframe: Baseline, Week 48

Interventionseconds (Mean)
Es-citalopram and Memantine Treatment1.9

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Change in Trails B

Change from baseline to Week 48 on Trails B: Measures attention and executive function. It asks patients to connect numbers and letters in numerical to alphabetical order from (1-13 and A-L) as fast as they can. Patients are timed; the longer it takes for the patient to connect the numbers and letters, the worse their score. Unit of measure is in seconds. The amount of errors that the patient makes during trails is also recorded. (NCT01876823)
Timeframe: Baseline, Week 48

Interventionseconds (Mean)
Es-citalopram and Memantine Treatment-36.3

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Conversion to Dementia Using Clinical Dementia Rating (CDR)

The CDR is a numeric rating scale that is used to quantify the severity of one's cognitive function. The scale goes from 0=normal; 0.5=mild cognitive impairment; 1 to 3=mild to moderate/severe dementia. CDR was used a dichotomous outcome measure (no=0; yes=1). (NCT01876823)
Timeframe: Baseline, Week 48

Interventionparticipants (Number)
Es-citalopram and Memantine Treatment1

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Change in Clinical Global Impression - Cognitive Change

The CGI Cognitive Change follows a seven-point likert scale. Compared to the patient's condition at baseline in the study [prior to medication initiation], the patient's condition is rated as: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. Responses from the entire group were calculated. Mean at final visit and baseline is reported below. (NCT01876823)
Timeframe: Baseline, Week 48

Interventionunits on a scale (Mean)
CGI-Cognitive Change (Baseline)Clinical Global Impression-Cogntive Change (WK 48)
Es-citalopram and Memantine Treatment3.62.7

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Change in Clinical Global Impression - Depression Change

The CGI Depression Change follows a seven-point likert scale. Compared to the patient's condition at baseline in the study [prior to medication initiation], the patient's condition is rated as: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment. Responses were calculated for the entire group. Mean at final visit has been reported below. Higher mean at baseline indicates a decrease in depression scores. (NCT01876823)
Timeframe: Baseline, Week 48

Interventionunits on a scale (Mean)
Cognitive Global Impression at BaselineCognitive Global Impression at Final Visit (WK 48)
Es-citalopram and Memantine Treatment4.12.1

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Change in Treatment Emergent Side Effects (TESS)

"Somatic side effect rating scale which includes 26 common somatic side effects associated with previous medication clinical trials; rated by the study physician. Factors were dichotomized to yes or no responses on this scale, which equated to the symptom being either present or not present. Yes and no responses were given a value of 0 (no) or 1 (yes). Responses from the entire group were calculated and the mean at baseline and the last visit is reported below." (NCT01876823)
Timeframe: Baseline, Week 48

Interventionunits on a scale (Mean)
Treatment Emergent Side Effects (Baseline)Treatment Emergent Side Effects (WK 48)
Es-citalopram and Memantine Treatment6.63.2

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Change in Wechsler Memory Scale-III (WMS-III)

Change in Wechsler Memory Scale-III scores from baseline to Week 48: The WMS-III Visual Reproduction sub-test was used to measure visual working memory and delayed memory. Patients were shown pictures of four drawings and were asked to reproduce them from memory immediately after seeing them, and 25 minutes after seeing them. The four scores are summed and the greater the total raw score, the better the patient did on the assessment. The maximum raw score for this test is a 41 on both the immediate and delayed portions (the overall range is 0-82 points). The change score is calculated using the total scores of both the immediate and delayed portions. (NCT01876823)
Timeframe: Baseline, Week 48

Interventionunits on a scale (Mean)
Es-citalopram and Memantine Treatment9.9

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Number of Participants With Adverse Events

The UKU (Udvalg for Kliniske Undersogelser) Side Effect Rating Scale organizes symptoms into 4 categories (i.e., Psychic, Neurologic, Autonomic, Other) containing 8-19 symptoms each. Each symptom receives a score for degree and causal relationship. Degree is scored between 0-3 with higher scores being more severe. Causal relationship is scored as improbable, possible, or probable. (NCT01902004)
Timeframe: Measured at 3, 6 months and 12 months

,
InterventionParticipants (Count of Participants)
3 Months6 Months12 Months
Escitalopram and Memantine331
Escitalopram and Placebo250

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Change in Montgomery Asberg Depression Rating Scale

Clinician administered item scale measures severity of depressive symptoms. The 10 items are measured on a 7-point scale ranging from 0 to 6; creating a total range of 0-60. A score of 0 suggests absence of symptoms and higher scores represent greater severity of depression.Severity gradations for the MADRS have been proposed (9-17 = mild, 18-34 = moderate, and ≥ 35 = severe). Treatment remission is defined as an endpoint total score ≤ 10. (NCT01902004)
Timeframe: Measured at 3 months; 6 months and 12 months

,
Interventionunits on a scale (Mean)
Baseline3 Months6 Months12 Months
Escitalopram and Memantine16.77.16.08.8
Escitalopram and Placebo14.88.78.68.0

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Change in Hamilton Depression Rating Scale

Clinician administered scale measures severity of depressive symptoms. This measure includes 24 items. Response options vary item to item and include the following ranges: [0-2], [0-3], and [0-4]. A score of 0 suggests absence of symptoms and/or difficulties and higher scores represent more severe difficulties. Possible overall score range [0-74], higher scores representing more severe difficulties. (NCT01902004)
Timeframe: Measured at 3 months; 6 months and 12 months

,
Interventionunits on a scale (Mean)
Baseline3 Months6 Months12 Months
Escitalopram and Memantine17.86.05.97.2
Escitalopram and Placebo17.76.76.95.4

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Change in Cognitive Domain Scores

Neuropsychological battery of tests which included the following domains: learning, delayed recall, and executive functioning. Raw scores were transformed to z-scores for each test score of interest for each participant, and then averaged. These z-scores were averaged within each neuropsychological domain to produce composite scores and then averaged over all tests to calculate a global performance score. Higher scores are indicative of better performance. (NCT01902004)
Timeframe: Measured at 6 months and 12 months

,
Interventionz score (Mean)
Baseline6 Months12 Months
Escitalopram and Memantine.020.03.15
Escitalopram and Placebo-.04-.1-.26

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Money Earned

"Change in amount of money earned between baseline and after 6 weeks of antidepressant treatment is determined through a summary score from a variety of decision-making tasks. Participants received between $5 and $40 per visit, depending on the outcomes of the decisions made on the computerized tasks. Variable payment ensured that the decision-making tasks were approached realistically, as opposed to using hypothetical points that do not have meaning in the real world. Greater earnings indicate better financial decision-making.~The specific tasks were:~risk task~balloon analogue risk task~temporal discounting task~ultimatum game~continuous performance task" (NCT01916824)
Timeframe: Baseline, Week 6

,
InterventionUS Dollars (Mean)
Baseline VisitAfter 6 Weeks of Treatment
Healthy Controls25.021.9
Participants With Major Depressive Disorder23.220.5

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Quick Inventory of Depression Scale (QIDS-SR): Expectancy

This 16-items assessment is used to rate the 9 criterion symptom domains of a major depressive episode: 4 items are used to rate sleep disturbance (early, middle, and late insomnia plus hypersomnia); 2 items are used to rate psychomotor disturbance (agitation and retardation); 4 items are used to rate appetite/weight disturbance (appetite increase or decrease and weight increase or decrease). Only 1 item is used to rate the remaining 6 domains (depressed mood, decreased interest, decreased energy, worthlessness/guilt, concentration/decision making, and suicidal ideation). Each item is rated 0-3. For symptom domains that require more than 1 item, the highest score of the item relevant for each domain is taken. The total score ranges from 0-27. A lower rating indicates higher expectancy of improvement and lower expectation of depressive symptomatology, and a higher rating indicates lower expectancy of improvement, higher expectation of depression. (NCT01931202)
Timeframe: Pre-Baseline

Interventionunits on a scale (Mean)
Double Blind-Placebo Group5.3
Double Blind-Escitalopram Group4.8
Open Treatment With Escitalopram5.8

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White Matter Hyperintensity (WMH) Outcome- Total WMH

Magnetic Resonance Imaging (MRI) of the Brain was acquired. We rated the severity of WMH on axial T2 FLAIR images using the Fazekas modified Coffey Rating Scale. Deep WMH are scored as 0 (absent), 1 (punctate foci), 2 (beginning confluence of foci), and 3 (large confluent areas); subcortical gray matter HIs (basal ganglia) are scored as 0 (absent), 1 (punctate), 2 (multipunctate), and 3 (diffuse); periventricular HIs are scored as 0 (absent), 1 (caps), 2 (smooth halo), and 3 (irregular and extending into the deep white matter). Our primary measure of WMH burden will be DWMH score, which has been used to establish the only empirically validated diagnostic criteria for vascular depression, where scores of 0-1 were normal, but 2-3 indicated WHM. (NCT01931202)
Timeframe: Pre-Baseline

Interventionscore on a scale (Mean)
Double Blind-Placebo Group2.3
Double Blind-Escitalopram Group2.1
Open Treatment With Escitalopram1.9

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Quick Inventory of Depressive Symptoms (QIDS-SR)

QIDS-SR is a 16 item scale self-report form that was used to measure depression outcomes. This self-report is valuable in this study, because it is less susceptible to clinician and rater bias. The QIDS-SR has been increasingly used in antidepressant studies due to its equivalent weightings for each symptom item, clearly understandable anchor points, and inclusion of all DSM criteria for depression. The scores range from 0-27 with 27 being worse depressive symptoms. (NCT01931202)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Double Blind-Placebo Group8.00
Double Blind-Escitalopram Group6.93
Open Treatment With Escitalopram6.34

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Quick Inventory of Depressive Symptoms (QIDS-SR)

QIDS-SR is a 16 item scale self-report form that was used to measure depression outcomes. This self-report is valuable in this study, because it is less susceptible to clinician and rater bias. The QIDS-SR has been increasingly used in antidepressant studies due to its equivalent weightings for each symptom item, clearly understandable anchor points, and inclusion of all DSM criteria for depression. The scores range from 0-27 with 27 being worse depressive symptoms. (NCT01931202)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Double Blind-Placebo Group12.4
Double Blind-Escitalopram Group13.5
Open Treatment With Escitalopram13.0

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Quick Inventory of Depression Scale (QIDS-SR): Expectancy

This 16-items assessment is used to rate the 9 criterion symptom domains of a major depressive episode: 4 items are used to rate sleep disturbance (early, middle, and late insomnia plus hypersomnia); 2 items are used to rate psychomotor disturbance (agitation and retardation); 4 items are used to rate appetite/weight disturbance (appetite increase or decrease and weight increase or decrease). Only 1 item is used to rate the remaining 6 domains (depressed mood, decreased interest, decreased energy, worthlessness/guilt, concentration/decision making, and suicidal ideation). Each item is rated 0-3. For symptom domains that require more than 1 item, the highest score of the item relevant for each domain is taken. The total score ranges from 0-27. A lower rating indicates higher expectancy of improvement and lower expectation of depressive symptomatology, and a higher rating indicates lower expectancy of improvement, higher expectation of depression. (NCT01931202)
Timeframe: Week 0

Interventionunits on a scale (Mean)
Double Blind-Placebo Group6.63
Double Blind-Escitalopram Group6.20
Open Treatment With Escitalopram4.92

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Credibility and Expectancy Scale-Better (CES)

CES is an 8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. Question 2 ('Better') asks the patient the chances of their depression being completely better at the end of this study, from 1 = very poor to 7 = very good. The higher the number, the higher the expectancy that they will be better. (NCT01931202)
Timeframe: Week 0

Interventionunits on a scale (Mean)
Double Blind-Placebo Group5.63
Double Blind-Escitalopram Group5.00
Open Treatment With Escitalopram5.67

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Credibility and Expectancy Scale-Depression

CES is an 8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. CES question 3 ('Depression') asks how the patient's depression will be at the end of the study, compared with now, from 1 = much worse to 7= much better. The higher the number, the higher the expectancy that their depression will be much better. (NCT01931202)
Timeframe: Pre-baseline

Interventionunits on a scale (Mean)
Double Blind-Placebo Group6.3
Double Blind-Escitalopram Group6.0
Open Treatment With Escitalopram5.9

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Credibility and Expectancy Scale-Depression

CES is an 8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. CES question 3 ('Depression') asks how the patient's depression will be at the end of the study, compared with now, from 1 = much worse to 7= much better. The higher the number, the higher the expectancy that their depression will be much better. (NCT01931202)
Timeframe: Week 0

Interventionunits on a scale (Mean)
Double Blind-Placebo Group5.88
Double Blind-Escitalopram Group5.40
Open Treatment With Escitalopram6.06

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Executive Dysfunction: Stroop Color Word

Stroop Color Word test asks patients to name the color of a word rather than reading the word. Stroop Color Word is how many colors they can name in 45 sec (higher is better, e.g., less executive dysfunction). (NCT01931202)
Timeframe: Pre-Baseline

Interventioncorrect items (Mean)
Double Blind-Placebo Group31.7
Double Blind-Escitalopram Group31.0
Open Treatment With Escitalopram32.6

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Executive Dysfunction: Stroop Interference

The Stroop is a measure of inhibition under distracting conditions that is sensitive to frontal lobe dysfunction. in Stroop Color Word test patients are to name the color of a word rather than reading the word. Stroop Color Word is how many colors they can name in 45 sec (higher is better, e.g., less executive dysfunction). Stroop Interference is this score adjusted for age and education. (NCT01931202)
Timeframe: Pre-Baseline

Interventioncorrect items (Mean)
Double Blind-Placebo Group42.2
Double Blind-Escitalopram Group42.9
Open Treatment With Escitalopram44.1

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Hamilton Rating Scale for Depression (HRSD)

Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluate recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score of 16 or above is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. (NCT01931202)
Timeframe: Baseline

Interventionunits on a scale (Mean)
Double Blind-Placebo Group22.8
Double Blind-Escitalopram Group23.6
Open Treatment With Escitalopram22.9

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Hamilton Rating Scale for Depression (HRSD)

Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluate recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score of 16 or above is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. (NCT01931202)
Timeframe: Week 8

Interventionunits on a scale (Mean)
Double Blind-Placebo Group13.25
Double Blind-Escitalopram Group14.39
Open Treatment With Escitalopram11.67

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Credibility and Expectancy Scale-Better (CES)

CES is an 8 item scale in which subjects rate their impression of the credibility of the treatment and how they estimate their expectation of improvement. The CES is the most widely used measure of expectancy and has demonstrated good psychometric properties in multiple studies. Question 2 ('Better') asks the patient the chances of their depression being completely better at the end of this study, from 1 = very poor to 7 = very good. The higher the number, the higher the expectancy that they will be better. (NCT01931202)
Timeframe: Pre-Baseline

Interventionunits on a scale (Mean)
Double Blind-Placebo Group6
Double Blind-Escitalopram Group5.5
Open Treatment With Escitalopram5.3

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Hamilton Depression Rating Scale: Stratified by Baseline Frailty

Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. (NCT01973283)
Timeframe: Month 6

Interventionscore on a scale (Mean)
Frail14.8
Not/Intermediate Frail10.8

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Hamilton Depression Rating Scale: Stratified by Baseline Frailty

Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. (NCT01973283)
Timeframe: Week 8

Interventionscore on a scale (Mean)
Frail15.1
Not/Intermediate Frail11.6

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Hamilton Rating Scale for Depression (HRSD)

Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. (NCT01973283)
Timeframe: 6 Months

Interventionscore on a scale (Mean)
Medication Treatment12.5

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Hamilton Rating Scale for Depression (HRSD)

Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. (NCT01973283)
Timeframe: Week 8

Interventionscore on a scale (Mean)
Medication Treatment13.3

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World Health Organization Disability Assessment 2.0 (36-item)

"Assesses the level of functioning of patients, a component of the frailty evaluation. Simple: the scores assigned to each of the items - none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. This method is referred to as simple scoring because the scores from each of the items are simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. This approach is practical to use as a hand-scoring approach and may be the method of choice in busy clinical settings or in paper-pencil interview situations. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.~Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability)." (NCT01973283)
Timeframe: Week 8

Interventionscore on a scale (Mean)
Medication Treatment68.7

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World Health Organization Disability Assessment 2.0 (36-item)

"Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.~Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability)." (NCT01973283)
Timeframe: 12 Months

Interventionscore on a scale (Mean)
Medication Treatment67.8

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World Health Organization Disability Assessment 2.0 (36-item)

"Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.~Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability)." (NCT01973283)
Timeframe: 6 Months

Interventionscore on a scale (Mean)
Medication Treatment66.7

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World Health Organization Disability Assessment 2.0 (36-item)

"Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.~Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability)." (NCT01973283)
Timeframe: Baseline (Week 0)

Interventionscore on a scale (Mean)
Medication Treatment71.7

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World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty

"Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.~Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability)." (NCT01973283)
Timeframe: Month 12

Interventionscore on a scale (Mean)
Frail80.9
Not/Intermediate Frail56.7

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World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty

"Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.~Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability)." (NCT01973283)
Timeframe: Month 6

Interventionscore on a scale (Mean)
Frail77.2
Not/Intermediate Frail58.0

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World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty

"Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.~Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability)." (NCT01973283)
Timeframe: Week 8

Interventionscore on a scale (Mean)
Frail77.9
Not/Intermediate Frail59.4

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World Health Organization Disability Assessment 2.0 (36-item)--Stratified by Baseline Frailty

"Assesses the level of functioning of patients, a component of the frailty evaluation. The scores assigned to each of the items: none (0), mild (1) moderate (2), severe (3), and extreme (4) - are summed. Each of the items is simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. As a result, the simple sum of the scores of the items across all domains constitutes a statistic that is sufficient to describe the degree of functional limitations.~Step 1 - Summing of recoded item scores within each domain. Step 2 - Summing of all six domain scores. Step 3 - Converting the summary score into a metric ranging from 0 to 100 (where 0 = no disability; 100 = full disability)." (NCT01973283)
Timeframe: Baseline (Week 0)

Interventionscore on a scale (Mean)
Frail82.3
Not/Intermediate Frail56.8

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Hamilton Depression Rating Scale (HRSD)

Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. (NCT01973283)
Timeframe: 12 Months

Interventionscore on a scale (Mean)
Medication Treatment13.6

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Hamilton Depression Rating Scale: Stratified by Baseline Frailty

Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. (NCT01973283)
Timeframe: Baseline (Week 0)

Interventionscore on a scale (Mean)
Frail21
Not/Intermediate Frail19.7

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Hamilton Depression Rating Scale: Stratified by Baseline Frailty

Measure Description: Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. (NCT01973283)
Timeframe: Month 12

Interventionscore on a scale (Mean)
Frail14.3
Not/Intermediate Frail13.0

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fMRI Brain Activation in Right Inferior Frontal Gyrus

Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score. (NCT02080832)
Timeframe: Baseline

InterventionPercent of significant voxels in cluster (Number)
Citalopram (20mg or 40mg)83
Placebo0

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fMRI Brain Activation in Right Precentral Gyrus

Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score. (NCT02080832)
Timeframe: Baseline

Interventionpercent of significant voxels in cluster (Number)
Citalopram (20mg or 40mg)9
Placebo0

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fMRI Brain Activation in Right Orlandic Operculum

Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score. (NCT02080832)
Timeframe: Baseline

Interventionpercent of significant voxels in cluster (Number)
Citalopram (20mg or 40mg)8
Placebo0

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Cocaine Use/Treatment Effectiveness Score (TES)

Number of benzoylecgonine negative urines divided by the total number of urines collected (NCT02080832)
Timeframe: 8 weeks of treatment

Interventionpercentage of negative urines (Number)
Medication (Citalopram 20mg)6.6
Placebo8.3
Medication (Citalopram 40mg)29

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Hamilton Rating Scale for Depression

"scale for depressive symptoms administered by trained rater. The HRSD is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. Although the HRSD list 21 items, the scoring is based on the first 17 items.~sum of the scores of the first 17 items (range from 0 to 54): 0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression >=23 = Very Severe Depression" (NCT02082392)
Timeframe: Baseline week

Interventionunits on a scale (Mean)
Clinical Frequency Management25
Research Frequency Management31

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Hamilton Anxiety Rating Scale (HARS) 14-item Scale

Scale for anxiety symptoms administered by trained rater. The HARS is a standard measure of anxiety severity in pharmacotherapy studies that has been shown to have acceptable reliability and validity in studies of depressed patients. Each item is scored on a scale of 0 (not present) to 4(severe), with a total score range of 0-56, where <17 indi-cates mild severity, 18-24 mild to moderate severity and25-30 moderate to severe. (NCT02082392)
Timeframe: Baseline week

Interventionunits on a scale (Mean)
Clinical Frequency Management9.5
Research Frequency Management13

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CGI Severity and Improvement

"scales developed to measure the clinician's view of subjects' global functioning before and after initiating a study medication. The CGI correlates well with other standard outcome measures for depression (e.g., HRSD), is sensitive to change in antidepressant trials, and offers clinically understandable anchor points.~7-point scale: 0 = Not assessed 4 = Moderately ill~1 = Normal, not at all ill 5 = Markedly ill 2 = Borderline mentally ill 6 = Severely ill 3 = Mildly ill 7 = Among the most extremely ill patients" (NCT02082392)
Timeframe: Baseline week

Interventionunits on a scale (Mean)
Clinical Frequency Management3
Research Frequency Management4

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Number of Remission From Major Depressive Episode Events

Remission from major depressive episode as assessed by 17-item Hamilton Depression Rating Scale. (NCT02137369)
Timeframe: 12 weeks

Interventionnumber of events (Number)
SSRI15
Cognitive Behavioral Therapy4

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Number of Response to Treatment Events

Response Defined as 50% Change in Hamilton Depression Rating Scale-17 Score at 12 Weeks (NCT02137369)
Timeframe: 12 weeks

Interventionnumber of events (Number)
SSRI21
Cognitive Behavioral Therapy5

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Amyloid Beta Levels in CSF

Change in the level of Amyloid Beta peptides (Amyloid Beta 42 and Amyloid Beta 40) in the CSF between the measurement at baseline and the measurement after exposure with escitalopram. (NCT02161458)
Timeframe: 2 - 8 Weeks (we used week 8 minus baseline and week 2 minus baseline)

,,,
Interventionpg/mL (Mean)
Ab 42 in CSFAb 40 in CSF
Escitalopram 20mg for 2 Weeks-12.746.27
Escitalopram 20mg for 8 Weeks-25.63-41.82
Escitalopram 30mg for 8 Weeks-22.73-152.64
Placebo (Sugar Pill)6.74197.36

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Number of Participants With Urinalysis Data Outside the Normal Range

Urine samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Number of participants with urine specific gravity and potential of hydrogen (pH) outside (higher or lower) the normal range are presented. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10

,
InterventionParticipants (Number)
Urine specific gravity, high,Screening, n=265, 255Urine specific gravity, low,Screening, n=265, 255Urine specific gravity,high, Week 8, n=171, 173Urine specific gravity,low, Week 8, n=171, 173Urine specific gravity, high, Taper, n=18, 28Urine specific gravity, low, Taper, n=18, 28Urine specific gravity, high, Follow-up, n=7, 14Urine specific gravity, low, Follow-up, n=7, 14Urine pH, high, Screening, n=265, 266Urine pH, low, Screening, n=265, 266Urine pH, high, Week 8, n=172, 178Urine pH, low, Week 8, n=172, 178Urine pH, high, Taper, n=18, 28Urine pH, low, Taper, n=18, 28Urine pH, high, Follow-up, n=7, 14Urine pH, low, Follow-up, n=7, 14
Bupropion XL2019000007375230202
Escitalopram12171013018289201202

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Number of Participants With Suicidal Ideation or Behavior During Treatment Assessed by Columbia Suicide Severity Rating Scale (C-SSRS)

"C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. It consists of 10 items, each with two possible answers (yes/no). Suicidal ideation was interpreted if yes answer at any time during treatment to any one of the five suicidal ideation questions (item 1-5) on the C-SSRS. Suicidal behavior was interpreted if a yes answer at any time during treatment to any one of the five suicidal behavior questions (item 6-10) on the C-SSRS. Suicidal ideation or behavior is interpreted if a yes answer at any time during treatment to any one of the ten suicidal ideation and behavior questions (item 1-10) on the C-SSRS. Number of participants with at least one on-treatment C-SSRS assessment were analyzed. Only those participants with data available at the specified time points were analyzed." (NCT02191397)
Timeframe: Baseline and up to Taper visit (Week 9)

,
InterventionParticipants (Number)
Suicidal Ideation or BehaviorSuicidal IdeationSuicidal BehaviorSelf-Injurious Behavior, no suicidal attempt
Bupropion XL505021
Escitalopram434311

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Number of Participants With Electrocardiogram (ECG) Data Outside the Clinical Concern Range

ECG was recorded at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). PR interval <110 or >220 millisecond (msec); QRS interval <60 or >120 msec and corrected QT (QTc) interval >450 msec were considered as values outside of clinical concern range and were presented as 'High' or 'Low' values. Number of participants with ECG data outside of clinical concern range at any post-Baseline visit are presented. Only those participants with data available at the specified time points were analyzed. (NCT02191397)
Timeframe: Up to Week 10

,
InterventionParticipants (Number)
PR interval, high, Any visit post-randomizationPR interval, low,Any visit post-randomizationQRS interval, high, Any visit post-randomizationQRS interval, low, Any visit post-randomizationQTc interval, high, Any visit post-randomizationQTc interval, low, Any visit post-randomization
Bupropion XL052010
Escitalopram023130

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Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious AE (SAE)

An AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or all events of possible drug-induced liver injury with hyperbilirubinemia were categorized as SAE. Participants who received any of the study treatment and had any non-serious AE or SAE were considered for analysis. Safety Population comprised of all participants who took at least one dose of the study medication. (NCT02191397)
Timeframe: Up to Week 10

,
InterventionParticipants (Count of Participants)
Any non-serious AEAny SAE
Bupropion XL15110
Escitalopram15011

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Change From Baseline in White Blood Cell (WBC) Count, Total Neutrophil, Lymphocyte, Basophil, Eosinophil, Monocyte and Platelet Count at the Indicated Time Points

Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10

,
InterventionGiga cells per liter (GI/L) (Mean)
WBC count, Week 8, n=176, 183WBC count, Taper, n=13, 16WBC count, Follow-up, n=10, 8Total Neutrophils, Week 8, n=176, 183Total Neutrophils, Taper, n=13, 16Total Neutrophils, Follow-up, n=10, 8Lymphocytes, Week 8, n=176, 183Lymphocytes, Taper, n=13, 16Lymphocytes, Follow-up, n=10, 8Basophil, Week 8, n=176, 182Basophil, Taper, n=13, 16Basophil, Follow-up, n=10, 8Eosinophil, Week 8, n=176, 182Eosinophil, Taper, n=13, 16Eosinophil, Follow-up, n=10, 8Monocyte, Week 8, n=176, 182Monocyte, Taper, n=13, 16Monocyte, Follow-up, n=10, 8Platelet count, Week 8, n=176, 183Platelet count, Taper, n=13, 16Platelet count, Follow-up, n=10, 8
Bupropion XL-0.0320.065-0.7430.1010.306-0.869-0.154-0.2420.0420.0010.001-0.003-0.004-0.012-0.0050.021-0.0010.0587.7317.1528.50
Escitalopram-0.073-0.7150.427-0.165-0.7720.4240.0720.0770.0220.0020.001-0.0120.0100.0060.0190.003-0.0310.0100.567.195.38

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Change From Baseline in Total Bilirubin, Direct Bilirubin and Creatinine at the Indicated Time Points

Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10

,
InterventionMicromoles per liter (µmol/L) (Mean)
Total bilirubin, Week 8, n=175, 181Total bilirubin, Taper, n=12, 15Total bilirubin, Follow-up, n=8, 12Direct bilirubin, Week 8, n=175, 180Direct bilirubin, Taper, n=11, 15Direct bilirubin, Follow-up, n=8, 12Creatinine, Week 8, n=174, 183Creatinine, Taper, n=12, 15Creatinine, Follow-up, n=8, 11
Bupropion XL-0.812-3.4570.382-0.072-1.554-0.1027.5076.6754.237
Escitalopram-0.0711.1980.338-0.0060.6540.3820.3070.8801.618

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Change From Baseline in Red Blood Cell (RBC) Count at the Indicated Time Points

Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10

,
Intervention10^12 cells per liter (Mean)
RBC Count, Week 8, n=176, 183RBC Count, Taper, n=13, 16RBC Count, Follow-up, n=10, 8
Bupropion XL-0.009-0.088-0.132
Escitalopram-0.049-0.0070.036

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Change From Baseline in Mean Corpuscle Volume (MCV) at the Indicated Time Points

Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10

,
InterventionFemtoliter (Mean)
MCV, Week 8, n=176, 183MCV, Taper, n=13, 16MCV, Follow-up, n=10, 8
Bupropion XL4.6680.5080.320
Escitalopram-0.0900.1810.287

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Change From Baseline in Mean Corpuscle Hemoglobin (MCH) at the Indicated Time Points

Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10

,
InterventionPicograms (Mean)
MCH, Week 8, n=176, 183MCH, Taper, n=13, 16MCH, Follow-up, n=10, 8
Bupropion XL-0.0320.269-0.050
Escitalopram0.0490.262-0.250

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Change From Baseline in Hematocrit at the Indicated Time Points

Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10

,
InterventionProportion of red blood cells in blood (Mean)
Hematocrit, Week 8, n=176, 183Hematocrit, Taper, n=13, 16Hematocrit, Follow-up, n=10, 8
Bupropion XL0.0016-0.0051-0.0076
Escitalopram-0.00440.00170.0051

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Change From Baseline in HAMD-17 Sleep Disorder Subscale Score (Sum of Scores of Items 4, 5 and 6) at Weeks 1, 2, 4, 6 and 8

HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Sleep Disorder subscale score was derived as sum of scores of items 4, 5 and 6 from HAMD-17. This subscale has a score in a range of 0 (absence of condition) to 6 (most severe condition). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8

,
InterventionScores on a scale (Least Squares Mean)
Week 1, n=184, 199Week 2, n=182, 199Week 4, n=184, 198Week 6, n=183, 197Week 8, n=176, 188
Bupropion XL-0.6-0.8-1.4-1.8-2.3
Escitalopram-0.7-1.2-1.6-2.0-2.4

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Change From Baseline in HAMD-17 Retardation Subscale Score (Sum of Scores of Items 1, 7, 8 and 14) at Weeks 1, 2, 4, 6 and 8

HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Retardation subscale score was derived as sum of scores of items 1, 7, 8 and 14 from HAMD-17. This subscale has a score in a range of 0 (absence of condition) to 14 (most severe condition). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8

,
InterventionScores on a scale (Least Squares Mean)
Week 1, n=184, 199Week 2, n=182, 199Week 4, n=184, 198Week 6, n=183, 197Week 8, n=176, 188
Bupropion XL-1.0-1.8-2.9-3.9-4.7
Escitalopram-1.0-2.0-3.1-3.9-4.9

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Change From Baseline in HAMD-17 Depressed Mood Subscale Score (Score of Item 1) at Weeks 1, 2, 4, 6 and 8

HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Depressed Mood Subscale is a factor score of item-1 (Depressed Mood) of HAMD-17 scale. This subscale has a score in a range of 0 (absence of depressed mood feelings) to 4 (when participants report virtually only these feeling states in his/her spontaneous verbal and non-verbal communicationtotal score). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8

,
InterventionScores on a scale (Least Squares Mean)
Week 1, n=184, 199Week 2, n=182, 199Week 4, n=184, 198Week 6, n=183, 197Week 8, n=176, 188
Bupropion XL-0.4-0.7-1.1-1.5-1.9
Escitalopram-0.4-0.8-1.3-1.6-1.9

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Change From Baseline in HAMD-17 Anxiety/Somatization Subscale Score (Sum of Scores of Items 10, 11, 12, 13, 15 and 17) at Weeks 1, 2, 4, 6 and 8

HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 Anxiety/Somatization subscale score was derived as sum of scores of items 10, 11, 12, 13, 15 and 17 from HAMD-17. This subscale has a score in a range of 0 (absence of condition) to 18 (most severe condition). Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was calculated by subtracting the Baseline response from the specific post-Baseline response. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8

,
InterventionScores on a scale (Least Squares Mean)
Week 1, n=184, 199Week 2, n=182, 199Week 4, n=184, 198Week 6, n=183, 197Week 8, n=176, 188
Bupropion XL-1.3-2.0-3.0-4.0-4.8
Escitalopram-1.1-2.4-3.4-4.4-5.1

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Change From Baseline in Clinical Global Impression-Severity of Illness Scale (CGI-S) Score at Weeks 1, 2, 4, 6 and 8

"CGI-S records the severity of illness at specific time points, with a range of responses from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). Participants with zero values (0) representing Not assessed were excluded from analysis. Values at Day 0, Week 0 was considered as Baseline value. Change from Baseline was obtained by subtracting the Baseline value from the specific post-Baseline value. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points." (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8

,
InterventionScores on a scale (Least Squares Mean)
Week 1, n=184, 199Week 2, n=182, 199Week 4, n=184, 198Week 6, n=183, 197Week 8, n=176, 188
Bupropion XL-0.3-0.7-1.1-1.6-2.1
Escitalopram-0.4-0.8-1.3-1.7-2.2

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Change From Baseline in Calcium, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at the Indicated Time Points

Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10

,
InterventionMillimole per liter (mmol/L) (Mean)
Calcium, Week 8, n=173, 183Calcium, Taper, n=12, 12Calcium, Follow-up, n=8, 11Chloride, Week 8, n=173, 182Chloride, Taper, n=10, 13Chloride, Follow-up, n=8, 8Cholesterol, Week 8, n=175, 181Cholesterol, Taper, n=12, 14Cholesterol, Follow-up, n=9, 11Glucose, Week 8, n=173, 181Glucose, Taper, n=12, 16Glucose, Follow-up, n=9, 11Potassium, Week 8, n=173, 182Potassium, Taper, n=10, 13Potassium, Follow-up, n=8, 8Sodium, Week 8, n=173, 182Sodium, Taper, n=10, 13Sodium, Follow-up, n=8, 8Triglycerides, Week 8, n=175, 181Triglycerides, Taper, n=13, 15Triglycerides, Follow-up, n=9, 11Urea, Week 8, n=174, 183Urea, Taper, n=12, 16Urea, Follow-up, n=8, 11
Bupropion XL-0.017-0.019-0.0600.259-0.498-0.287-0.1220.022-0.124-0.0510.352-0.194-0.021-0.114-0.110-0.205-0.611-0.1750.003-0.0320.637-0.0680.5170.687
Escitalopram-0.0200.012-0.060-0.293-0.566-0.1780.0510.082-0.122-0.0500.1060.0250.0090.0460.036-0.1780.9780.7700.0220.5740.1810.015-0.269-0.419

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Mean Change in Hamilton Depression Rating Scale - 17 (HAMD-17) Total Score From Baseline to End of Acute Treatment Phase (Week 8)

HAMD-17 is used to assess the severity of depression and symptom improvement. It consisted of 17 questions. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Change from Baseline was calculated by subtracting the Baseline total score (at Day 0, Week 0) from Week 8 observed total score. The Per Protocol (PP) Population is defined as all randomized participants in the Intent-To-Treat (ITT) Population who do not meet criteria of a major protocol deviation, with overall compliance of active drug for acute treatment phase in the range of 75%-125% and complete the first 6 weeks treatment and has HAMD-17 assessment at/after week 6 (that is >=35 days). All participants in the PP population were included in the mixed model repeated measures analysis. Only those participants with data available at the specified time point were analyzed. (NCT02191397)
Timeframe: Baseline (Week 0) and Week 8

InterventionScores on a scale (Least Squares Mean)
Bupropion XL-14.5
Escitalopram-15.4

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Change From Baseline in Changes in Sexual Function Questionnaire (CSFQ)

CSFQ is a questionnaire about sexual activity and sexual function (sexual intercourse, masturbation, sexual fantasies and other activity). CSFQ is a gender-specific questionnaire. Both male and female versions consist of 14 items, each with 5 possible answers. CSFQ has a score in a range of 14 to 70. Higher score indicates higher sexual activity and sexual function. Value at Day 0 (Week 0) was considered as Baseline value. Change from Baseline at Week 8 was calculated by subtracting the Baseline score from the specific post-Baseline score. Only those participants with data available at the specified time points were analyzed. (NCT02191397)
Timeframe: Baseline (Day 0) and Week 8

InterventionScores on a scale (Mean)
Bupropion XL3.0
Escitalopram0.9

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Remission Rate Based on HAMD-17 Total Score

HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Remission was defined as HAMD-17 total scores at end of acute treatment phase (Week 8) <=7. (NCT02191397)
Timeframe: Up to Week 8

InterventionPercentage of Participants (Number)
Bupropion XL39.7
Escitalopram47.2

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Number of Participants With Vital Sign Parameters Outside the Clinical Concern Range

Vital signs including systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were taken at Screening (within 14 days prior to dosing), randomization visit (Week 0) and at Weeks 1, 2, 4, 6, 8, Taper visit (Week 9) and Follow-up visit (Week 10). SBP <30 or >170 millimeter of mercury (mmHg); DBP <20 or >110 mmHg and heart rate <40 or >120 beats per minute (bpm) were considered as values outside of clinical concern range and were presented as 'High' or 'Low' values. Number of participants with vital signs outside of clinical concern range at any post-Baseline visit are presented. Only those participants with data available at the specified time points were analyzed. (NCT02191397)
Timeframe: Up to Week 10

,
InterventionParticipants (Number)
SBP, high, Any visit post-BaselineSBP, low,Any visit post-BaselineDBP, high, Any visit post-BaselineDBP, low, Any visit post-BaselineHR, high, Any visit post-BaselineHR, low, Any visit post-Baseline
Bupropion XL100000
Escitalopram000010

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Change From Baseline in Hemoglobin, Total Protein, Albumin and Mean Corpuscle Hemoglobin Concentration (MCHC) at the Indicated Time Points

Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10

,
InterventionGram per Liter (G/L) (Mean)
Hemoglobin, Week 8, n=176, 183Hemoglobin, Taper, n=13, 16Hemoglobin, Follow-up, n=10, 8Total protein, Week 8, n=174, 183Total protein, Taper, n=12, 15Total protein, Follow-up, n=8, 12Albumin, Week 8, n=175, 183Albumin, Taper, n=12, 15Albumin, Follow-up, n=8, 12MCHC, Week 8, n=176, 183MCHC, Taper, n=13, 16MCHC, Follow-up, n=10, 8
Bupropion XL-0.22-1.54-3.10-0.6401.197-4.650-0.254-0.086-1.925-0.090.54-2.10
Escitalopram-1.161.380.38-0.8912.000-1.227-0.678-0.027-1.5770.762.25-2.88

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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Weeks 1, 2, 4, 6 and 8

MADRS is a 10-point rating scale. Each item is scored on a scale of 0-6, with a total score range of 0-60. Higher score indicates worst symptoms. This scale is mainly used to assess the efficacy of antidepressant treatment. The ratings were based on the signs and symptoms during the preceding week prior to the visit. Values at Day0, Week 0 was considered as Baseline value. The observed MADRS total score was considered as missing if any item is missing. Change from Baseline in MADRS was obtained by subtracting the Baseline value from the specific post-Baseline value. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points. (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8

,
InterventionScores on a scale (Least Squares Mean)
Week 1, n=184, 199Week 2, n=182, 199Week 4, n=184, 198Week 6, n=183, 196Week 8, n=176, 188
Bupropion XL-3.6-7.0-11.2-15.5-18.6
Escitalopram-3.8-8.3-12.4-16.3-19.5

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Change From Baseline in Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), Gamma-glutamyl Transpeptidase (GGT) and Lactose Dehydrogenase (LD) at the Indicated Time Points

Blood samples were collected at Screening (within 14 days prior to dosing) and at Week 8, Taper visit (Week 9) and Follow-up visit (Week 10). Baseline was considered as the value obtained at Screening. Change from Baseline was calculated by subtracting the Baseline value from the specific post-Baseline values. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). (NCT02191397)
Timeframe: Up to Week 10

,
InterventionInternational Units per liter (IU/L) (Mean)
ALT, Week 8, n=176, 183ALT, Taper, n=12, 16ALT, Follow-up, n=8, 12ALP, Week 8, n=176, 181ALP, Taper, n=12, 15ALP, Follow-up, n=7, 12AST, Week 8, n=176, 183AST, Taper, n=12, 16AST, Follow-up, n=8, 12GGT, Week 8, n=175, 181GGT, Taper, n=12, 15GGT, Follow-up, n=7, 12LD, Week 8, n=176, 182LD, Taper, n=13, 13LD, Follow-up, n=8, 10
Bupropion XL2.2547.993-7.3371.8663.6745.6430.3303.1930.9250.6881.403-2.0291.29214.46311.037
Escitalopram1.315-1.8125.9380.4073.480-3.9531.0990.3812.867-0.694-3.1333.9162.879-8.092-4.150

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Response Rate Based on HAMD-17 Total Score

HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Response was defined as decrease in HAMD-17 total scores at end of acute treatment phase (Week 8) relative to Baseline by at least 50%. Non-responder Imputation was used in calculation of rates. (NCT02191397)
Timeframe: Up to Week 8

InterventionPercentage of Participants (Number)
Bupropion XL69.6
Escitalopram72.9

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Sustained Remission Rate Based on HAMD-17 Total Score

HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Sustained remission was defined as remission at end of acute treatment phase and an earlier visit and non-missing HAMD-17 total scores at all visits between these two visits <=8. (NCT02191397)
Timeframe: Up to Week 8

InterventionPercentage of Participants (Number)
Bupropion XL25.5
Escitalopram28.6

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Sustained Response Rate Based on HAMD-17 Total Score

HAMD-17 is an extensively used tool to assess the severity of depression and symptom improvement during the treatment. The HAMD-17 adopted for this study consisted of 17 questions with multiple choice responses, each of which is numerically scored. The HAMD-17 total score is calculated by summing the individual response scores if there is no missing response. HAMD-17 has a total score in a range of 0 (not present) to 52 (severe). Values at Day 0, Week 0 was considered as Baseline value. Sustained response was defined as response at end of acute treatment phase and an earlier visit and the decrease from Baseline in non-missing HAMD-17 total scores at all visits between these two visits by at least 40%. (NCT02191397)
Timeframe: Up to Week 8

InterventionPercentage of Participants (Number)
Bupropion XL51.6
Escitalopram56.3

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"Percentage of Participants With a Clinical Global Impression Global Improvement (CGI-I) Score of 1 (Very Much Improved) or 2 (Much Improved) at Weeks 1, 2, 4, 6 and 8"

"For CGI-I rating, the raters indicated their assessment of the participant's total improvement or worsening compared to the participant's condition at the Baseline visit, whether or not the improvement or worsening was thought to be treatment related. Scores ranges from 0 to 7 where 0 represents Not assessed, and the remaining values 1-7 represent Very much improved (1) to Very much worse (7). Participants with score 0 were excluded from analysis. All participants in the PP population were analyzed and n=X in the category titles represented the number of participants with data available at the specified time points." (NCT02191397)
Timeframe: Baseline (Week 0) and Weeks 1, 2, 4, 6 and 8

,
InterventionPercentage of Participants (Number)
Week 1, n=184, 199Week 2, n=182, 199Week 4, n=184, 198Week 6, n=183, 197Week 8, n=176, 188
Bupropion XL621.438.667.880.7
Escitalopram7.522.152.571.683.5

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Ruminative Response Scale (RRS)

The RRS is a self-report questionnaire assessing rumination, or responding to distress by passively focusing on the possible causes and consequences of one's distress. The RRS ranges from scores of 0-66, with higher scores indicating greater severity of rumination. Change is calculated as final RRS score - baseline RRS score, so a negative change indicates improvement in this symptom. (NCT02332291)
Timeframe: Baseline and Week 8

Interventionunits on a scale (Mean)
Blinded Escitalopram-10.27
Blinded Placebo-5.41

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Change in Depression Severity, Self Rated

Change in self-reported depression severity was measured by the Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16). This scale ranges from 0-27, with higher scores indicating greater depression severity. Change is calculated as final score less baseline score, so a negative value indicates a decrease in depression severity. (NCT02332291)
Timeframe: Week 8 to week 16

Interventionunits on a scale (Mean)
Open-label Bupropion XL-2.83

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Change in Depression Severity, Clinician Rated

Change in depression severity will be measured by the MADRS. Higher scores indicate greater depression severity, ranging 0-60. Change calculated as Final MADRS - Baseline MADRS, so a negative score means greater improvement. (NCT02332291)
Timeframe: Week 8 to week 16

Interventionunits on a scale (Mean)
Open-label Bupropion XL-8.75

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Number of Patients With Remission of Depression

Montgomery-Asberg Depression Rating Scale (MADRS) is a clinician-rated measure of depression severity. Higher scores indicate greater depression severity, ranging 0-60. This will be used to define remission as a final score of 7 or less (NCT02332291)
Timeframe: From Baseline up to Week 16

InterventionParticipants (Count of Participants)
Blinded Escitalopram / Open-Label Bupropion37
Blinded Placebo / Open-Label Bupropion13

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Change in Depression Severity, Self Rated

Self-rated depression severity was measured by the Quick Inventory of Depressive Symptoms, Self-Rated (QIDS-SR16). The QIDS-SR16 is a self-report of depression severity ranging from 0-27, with higher scores indicating greater depression severity. (NCT02332291)
Timeframe: Baseline to week 8

Interventionunits on a scale (Mean)
Blinded Escitalopram-4.87
Blinded Placebo-2.09

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Change in Depression Severity, Clinician Rated

Depression severity was measured by a study clinician using the MADRS. Higher scores indicate greater depression severity, ranging 0-60. Change calculated as Final MADRS - Baseline MADRS, so a negative score means greater improvement. (NCT02332291)
Timeframe: Baseline to week 8

Interventionscore on a scale (Mean)
Blinded Escitalopram-13.90
Blinded Placebo-6.09

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Apathy Evaluation Scale (AES)

The AES is a self-report scale of apathy symptoms. The scale ranges from 18-72, with higher scores indicating greater levels of apathy. Change is calculated as final AES score - baseline AES score, so a more negative value indicates greater improvement in that symptom. (NCT02332291)
Timeframe: Baseline and Week 8

Interventionunits on a scale (Mean)
Blinded Escitalopram-4.52
Blinded Placebo-3.00

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IL-6 Levels

IL6 levels were measured in participants by blood draw 6 weeks after the first dose was given. (NCT02389465)
Timeframe: up to week 6

Interventionpg/mL (Mean)
Healthy Control5.25
Placebo18.24
Escitalopram3.69
Escitalopram + Celecoxib6.84

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Montgomery Asberg Depression Rating Scale (MADRS)

"This depression rating scale will be used to determine clinical outcome for depressed participants.~Scores range from 0-60. The higher the score, the worse the outcome (see below)~Normal: 0-6 Mild Depression: 7-19 Moderate Depression: 20-34 Severe Depression: 35+ Very Severe Depression: 60" (NCT02389465)
Timeframe: Week 6

InterventionTotal Score (Sum of Points) (Mean)
Healthy Control1.27
Placebo19.14
Escitalopram14.04
Escitalopram + Celecoxib12.93

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IL10 Levels

IL10 levels were measured in participants by blood draw 6 weeks after the first dose was given (NCT02389465)
Timeframe: up to 6 weeks

Interventionpg/mL (Mean)
Healthy Control4.21
Placebo64.9
Escitalopram12.24
Escitalopram + Celecoxib18.56

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Percentage of Participants Who Achieved at Least 50% Reduction From Baseline in MADRS Total Score at Day 28 of Double-blind Induction Phase (Observed Data)

A participant was defined as a responder (yes=1 and no=0) at a given time point if the percent reduction from baseline in MADRS total score is at least 50 percent (%). The percentage of participants who achieved at least 50% reduction from baseline were reported. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. (NCT02417064)
Timeframe: At Day 28 of Double-blind Induction phase

InterventionPercentage of Participants (Number)
Intranasal Esketamine 56 mg Plus Oral Antidepressant54.1
Intranasal Esketamine 84 mg Plus Oral AD53.1
Oral AD Plus Intranasal Placebo38.9

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Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis

PHQ-9 is 9-item, self-reported scale assessing 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders, Major Depressive Disorder criteria. Each item is rated on 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half days, 3 = Nearly every day). The scores are summed for a total score ranging from 0-27. Higher score indicates greater severity of depression. Severity of PHQ-9 categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), Severe (20-27). The recall period is 2 weeks. (NCT02417064)
Timeframe: Baseline up to Day 28 of Double-blind Induction phase

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant-11.0
Intranasal Esketamine 84 mg Plus Oral AD-11.7
Oral AD Plus Intranasal Placebo-9.1

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Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis

"PHQ-9 is 9-item, self-reported scale assessing 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders, Major Depressive Disorder criteria. Each item is rated on 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half days, 3 = Nearly every day). The scores are summed for a total score ranging from 0-27. Higher score indicates greater severity of depression. Severity of PHQ-9 categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), Severe (20-27). The recall period is 2 weeks. Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant-10.9
Intranasal Esketamine 84 mg Plus Oral AD-10.9
Oral AD Plus Intranasal Placebo-8.9

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Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis

The SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1) work/school, 2) social life, and 3) family life/home responsibilities using 0 (not at all) to 10 (extremely) rating scale. Score for first 3 items are summed to create total score of 0 (unimpaired) to 30 (highly impaired), where higher score indicates greater impairment. (NCT02417064)
Timeframe: Baseline up to Day 28 of Double-blind Induction phase

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant-11.0
Intranasal Esketamine 84 mg Plus Oral AD-11.1
Oral AD Plus Intranasal Placebo-8.4

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Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis

"The SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1) work/school, 2) social life, and 3) family life/home responsibilities using 0 (not at all) to 10 (extremely) rating scale. Score for first 3 items are summed to create total score of 0 (unimpaired) to 30 (highly impaired) where higher score indicates greater impairment. Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant-10.7
Intranasal Esketamine 84 mg Plus Oral AD-10.2
Oral AD Plus Intranasal Placebo-8.1

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Percentage of Participants in Remission (MADRS<=12) at Day 28 of Double-blind Induction Phase (Observed Data)

Participants who had a MADRS total score of less than or equal to (<=) 12 were considered as remitters. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. (NCT02417064)
Timeframe: At Day 28 of Double-blind Induction Phase

InterventionPercentage of participants (Number)
Intranasal Esketamine 56 mg Plus Oral Antidepressant36
Intranasal Esketamine 84 mg Plus Oral AD38.8
Oral AD Plus Intranasal Placebo30.6

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Percentage of Participants in Remission (MADRS<=12) at the Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis (LOCF Data)

"Participants who had a MADRS total score of less than or equal to (<=) 12 were considered as remitters. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: At Day 28 (Double-blind Endpoint)

InterventionPercentage of participants (Number)
Intranasal Esketamine 56 mg Plus Oral Antidepressant34.8
Intranasal Esketamine 84 mg Plus Oral AD35.4
Oral AD Plus Intranasal Placebo29.2

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Percentage of Participants Who Achieved at Least 50% Reduction From Baseline in MADRS Total Score at the Endpoint (Double-blind Induction Phase [Day 28]) (LOCF Data)

"A participant was defined as a responder (yes=1 and no=0) at a given time point if the percent reduction from baseline in MADRS total score is at least 50 percent (%). The percentage of participants who achieved at least 50% reduction from baseline were reported. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: At Day 28 (Double-blind Endpoint)

InterventionPercentage of Participants (Number)
Intranasal Esketamine 56 mg Plus Oral Antidepressant53.0
Intranasal Esketamine 84 mg Plus Oral AD47.8
Oral AD Plus Intranasal Placebo37.2

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Percentage of Participants With Onset of Clinical Response by Day 2 and Day 8

A participant was defined as having a clinical response if there was at least 50% improvement (decrease) from baseline in the MADRS total score with onset by Day 2 and Day 8 that was maintained to Day 28. Participants were allowed one excursion (non-response) on Days 8, 15 or 22, however score must show at least 25% improvement. Participants who did not meet these criteria or discontinued during the study before Day 28 were considered as non-responders and were assigned the value of 0 (that is no). MADRS is clinician-rated scale that consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), for total possible score of 0 to 60. Higher scores represent more severe condition. (NCT02417064)
Timeframe: Day 2 up to Day 28 and Day 8 up to Day 28

,,
InterventionPercentage of Participants (Number)
Day 2 up to Day 28Day 8 up to Day 28
Intranasal Esketamine 56 mg Plus Oral Antidepressant10.413.0
Intranasal Esketamine 84 mg Plus Oral AD8.811.4
Oral AD Plus Intranasal Placebo1.83.5

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Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score up to Endpoint (Double-blind Induction Phase [Day 28])

"CGI-S provides measure of severity of participant's illness including participant's history, psychosocial circumstances, symptoms, behavior and impact of symptoms on ability to function. CGI-S evaluates severity of psychopathology on scale of 0 to 7. Considering total clinical experience, participant is assessed on severity of mental illness according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients (a decrease in score indicates improvement). Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)

InterventionUnits on a scale (Median)
Intranasal Esketamine 56 mg Plus Oral Antidepressant-2.0
Intranasal Esketamine 84 mg Plus Oral AD-2.0
Oral AD Plus Intranasal Placebo-1.0

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Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to End of Double-blind Induction Phase (Day 28): EQ-VAS

EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). (NCT02417064)
Timeframe: Baseline up to end of Double-blind induction phase (Day 28)

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant20.9
Intranasal Esketamine 84 mg Plus Oral AD19.1
Oral AD Plus Intranasal Placebo14.9

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Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to End of Double-blind Induction Phase (Day 28): Health Status Index

EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). The descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each has 5 levels (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses are used to generate Health Status Index (HSI). HSI range is -0.148 to 0.949, is anchored at 0 (dead) and 1 (full health). (NCT02417064)
Timeframe: Baseline up to End of Double-blind Induction Phase (Day 28)

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant0.224
Intranasal Esketamine 84 mg Plus Oral AD0.243
Oral AD Plus Intranasal Placebo0.181

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Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to End of Double-blind Induction Phase (Day 28): Sum Score

EQ-5D-5L measures health outcome self-completed by respondents. It consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). The descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each has 5 levels (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses are used to generate Health Status Index (HSI). HSI range is -0.148 to 0.949, is anchored at 0 (dead) and 1 (full health). EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state. (NCT02417064)
Timeframe: Baseline up to end of Double-blind Induction phase (Day 28)

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant-19.0
Intranasal Esketamine 84 mg Plus Oral AD-19.4
Oral AD Plus Intranasal Placebo-14.6

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Change From Baseline in Generalized Anxiety Disorder-7 Item (GAD-7) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])

"GAD-7 is a brief and validated 7-item self-reported assessment of overall anxiety. Participants responded to each item using a 4 point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15-21). Missing data was imputed using LOCF method and the last post baseline observation during the double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant-7.4
Intranasal Esketamine 84 mg Plus Oral AD-7.7
Oral AD Plus Intranasal Placebo-6.0

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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 of Double- Blind Induction Phase- Mixed- Effects Model Using Repeated Measures (MMRM) Analysis

MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. (NCT02417064)
Timeframe: Baseline up to Day 28 of Double-blind Induction Phase

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant-19.0
Intranasal Esketamine 84 mg Plus Oral AD-18.8
Oral AD Plus Intranasal Placebo-14.8

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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis

"MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Missing data was imputed using Last Observation Carried Forward (LOCF) method and last post baseline observation during double-blind induction phase was carried forward as End Point for that phase." (NCT02417064)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)

InterventionUnits on a scale (Mean)
Intranasal Esketamine 56 mg Plus Oral Antidepressant-18.3
Intranasal Esketamine 84 mg Plus Oral AD-17.4
Oral AD Plus Intranasal Placebo-14.3

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Change From Baseline in Generalized Anxiety Disorder (GAD-7) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])

"GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21). The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: Baseline up to Endpoint (Double-blind Induction Phase [Day 28])

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-7.9
Intranasal Placebo Plus Oral AD-6.8

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Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis

The SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. First three items assess disruption of 1 work/school, 2 social life, 3 family life/home responsibilities using a 0(no impairment)-10 (most severe impairment). Score for first 3 items are summed to create total score of 0-30 where higher score indicates greater impairment and a negative change in score indicates improvement. It also has one item on days lost from school or work and one item on days when under productive. (NCT02418585)
Timeframe: Baseline up to Day 28 of Double-blind Induction phase

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-13.6
Intranasal Placebo Plus Oral AD-9.4

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Change From Baseline in Sheehan Disability Scale (SDS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis

"The SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. First three items assess disruption of 1 work/school, 2 social life, 3 family life/home responsibilities using a 0(no impairment)-10 (most severe impairment). Score for first 3 items are summed to create total score of 0-30 where higher score indicates greater impairment and a negative change in score indicates improvement. It also has one item on days lost from school or work and one item on days when under productive. The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: Baseline up to Endpoint (Double-blind Induction Phase [Day 28])

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-12.5
Intranasal Placebo Plus Oral AD-9.3

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Percentage of Participants With Onset of Clinical Response on Day 2 and Day 8

A participant was defined as having a clinical response if there is at least 50 percent (%) improvement from baseline in the MADRS total score with onset by Day 2 and Day 8 that was maintained to Day 28. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Participants who did not meet such criterion or discontinue during the study before Day 28 for any reason were considered as non-responders. (NCT02418585)
Timeframe: Day 2 up to Day 28 and Day 8 up to Day 28

,
InterventionPercentage of participants (Number)
Onset of Clinical response on Day 2Onset of Clinical response on Day 8
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)7.910.5
Intranasal Placebo Plus Oral AD4.66.4

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Percentage of Participants in Remission (SDS Total Score <=6 and Individual Item Scores Each <=2) at the End of 4-Week Double-blind Induction Phase (Day 28)

Remission defined as SDS total score <= 6 and individual item scores each <= 2. SDS is a participant reported outcome measure and is a 5-item questionnaire which has been widely used and accepted for assessment of functional impairment and associated disability. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items were summed to create a total score of 0-30 where a higher score indicates greater impairment. It also has one item on days lost from school or work and one item on days when under productive. (NCT02418585)
Timeframe: At Day 28 (End of Double-blind Induction Phase)

InterventionPercentage of participants (Number)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)39.5
Intranasal Placebo Plus Oral AD20.9

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Percentage of Participants in Remission (MADRS<=12) at the Endpoint (Double-blind Induction Phase [Day 28])

"Remission was defined as participants who had a MADRS total score of less than or equal to (=<) 12. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: At Endpoint (Double-blind Induction Phase [Day 28])

InterventionPercentage of participants (Number)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)48.2
Intranasal Placebo Plus Oral AD30.3

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Percentage of Participants Who Achieved >=50% Reduction From Baseline in MADRS Total Score at the Endpoint (Double-blind Induction Phase [Day 28])

"MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. The percentage of participants with greater than or equal to (>=) 50 % reduction from baseline in MADRS total score was reported. The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: At Endpoint (Double-blind Induction Phase [Day 28])

InterventionPercentage of participants (Number)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)63.4
Intranasal Placebo Plus Oral AD49.5

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Percentage of Participants in Response (SDS Total Score <=12 and Individual Item Scores Each <=4) at the End of 4-Week Double-blind Induction Phase (Day 28)

Response defined as SDS total score <= 12 and individual item scores each <= 4. SDS is a participant-reported outcome measure and 5 item questionnaire used for assessment of functional impairment and associated disability. First three items assess disruption of 1 work/school, 2 social life, 3 family life/home responsibilities using a 0(no impairment)-10 (most severe impairment). Score for first 3 items are summed to create total score of 0-30 where higher score indicates greater impairment and a negative change in score indicates improvement. It also has one item on days lost from school or work and one item on days when under productive. (NCT02418585)
Timeframe: At Day 28 [end of Double-blind Induction Phase]

InterventionPercentage of participants (Number)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)57.0
Intranasal Placebo Plus Oral AD39.5

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Change From Baseline in EQ 5D-5L-Health Status Index to End of Double-blind Induction Phase (Day 28)

"European Quality of Life Group-5 Dimension-5-Level (EQ-5D-5L) is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). Health Status Index range is -0.148 - 0.949, is anchored at 0 (dead) and 1 (full health)." (NCT02418585)
Timeframe: Baseline up to End of Double-blind Induction Phase (Day 28)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)0.288
Intranasal Placebo Plus Oral AD0.231

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Change From Baseline in EQ 5D-5L- Sum Score to End of Double-blind Induction Phase (Day 28)

"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). Health Status Index range is -0.148 - 0.949, is anchored at 0 (dead) and 1 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT02418585)
Timeframe: Baseline up to End of Double-blind Induction Phase (Day 28)

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-23.2
Intranasal Placebo Plus Oral AD-17.1

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Change From Baseline in EQ 5D-5L- European Quality of Life - Visual Analogue Scale (EQ-VAS) to End of Double-blind Induction Phase (Day 28)

EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). (NCT02418585)
Timeframe: Baseline up to End of Double-blind Induction Phase (Day 28)

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)29.1
Intranasal Placebo Plus Oral AD20.9

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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Day 28 in the Double-blind Induction Phase- Mixed-Effects Model Using Repeated Measures (MMRM) Analysis

MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. (NCT02418585)
Timeframe: Baseline up to Day 28 of Double-blind Induction Phase

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-21.4
Intranasal Placebo Plus Oral AD-17.0

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Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- Analysis of Covariance (ANCOVA) Analysis

"MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: Baseline up to Endpoint (Double-blind Induction Phase [Day 28])

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-19.6
Intranasal Placebo Plus Oral AD-16.3

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Change From Baseline in Patient Health Questionnaire - 9-Item Depression Module (PHQ-9) Total Score up to Day 28 of Double-blind Induction Phase- MMRM Analysis

PHQ-9 is 9-item, self-report scale assessing depressive symptoms. Each item is rated on 4-point scale (0=Not at all, 1=Several Days, 2=More than half days, 3=Nearly every day. Scale scores each of 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders, Major Depressive Disorder criteria and it has been used both as screening tool and measure of response to treatment for depression. The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms. Severity of PHQ-9 categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), Severe (20-27). (NCT02418585)
Timeframe: Baseline up to Day 28 of Double-blind Induction phase

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-13.0
Intranasal Placebo Plus Oral AD-10.2

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Change From Baseline in Clinical Global Impression-Severity (CGI-S) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])

"CGI-S provides measure of severity of participant's illness including participant's history, psychosocial circumstances, symptoms, behavior and impact of symptoms on ability to function. CGI-S evaluates severity of psychopathology on scale of 0 to 7. Considering total clinical experience, participant is assessed on severity of mental illness according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among most extremely ill patients. CGI-S permits global evaluation of participant's condition at given time. The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: Baseline up to Endpoint (Double-blind Induction Phase [Day 28])

InterventionUnits on a scale (Median)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-2.0
Intranasal Placebo Plus Oral AD-2.0

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Change From Baseline in Patient Health Questionnaire - 9-Item Depression Module (PHQ-9) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis

"PHQ-9 is 9-item, self-report scale assessing depressive symptoms. Each item is rated on 4-point scale (0=Not at all, 1=Several Days, 2=More than half days, 3=Nearly every day). Scale scores each of 9 symptom domains of Diagnostic and Statistical Manual of Mental Disorders, Major Depressive Disorder criteria and it has been used both as screening tool and measure of response to treatment for depression. The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms. Severity of PHQ-9 categorized as follows: None-minimal (0-4), Mild (5-9), Moderate (10-14), Moderately Severe (15-19), Severe (20-27). The last post baseline observation during the phase was carried forward as End Point for that phase." (NCT02418585)
Timeframe: Baseline up to Endpoint (Double-blind Induction Phase [Day 28])

InterventionUnits on a scale (Mean)
Intranasal Esketamine (Esk) Plus Oral Antidepressant (AD)-12.2
Intranasal Placebo Plus Oral AD-10.1

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Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score to Endpoint (Double-blind Induction Phase [Day 28])- ANCOVA Analysis on Ranks

"CGI-S provides an overall clinician-determined summary measure of the severity of the participants illness including participants history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participants ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Missing data was imputed using LOCF method and last post baseline observation during the double-blind induction phase was carried forward as the End Point for that phase." (NCT02422186)
Timeframe: Baseline and Endpoint (Double-blind Induction Phase [Day 28])

InterventionUnits on a scale (Median)
Intranasal Esketamine Plus Oral Antidepressant (AD)-1.0
Oral AD Plus Intranasal Placebo0.0

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Percentage of Participants Who Achieved >=50% Reduction From Baseline in MADRS Total Score at Endpoint (Double-blind Induction Phase [Day 28]) (LOCF Data)

"Percentage of participants with greater than or equal to (>=50) percent (%) reduction from baseline are reported. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Missing data was imputed using LOCF method and last post baseline observation during the double-blind induction phase was carried forward as the End Point for that phase." (NCT02422186)
Timeframe: At Endpoint-Double-blind Induction Phase [Day 28]

InterventionPercentage of Participants (Number)
Intranasal Esketamine Plus Oral Antidepressant (AD)23.9
Oral AD Plus Intranasal Placebo12.5

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Percentage of Participants in Remission (MADRS<=12) at Endpoint (Double-blind Induction Phase [Day 28]) (LOCF Data)

"Remission was defined as participants who had a MADRS total score of less than or equal to (=<) 12. MADRS is clinician-rated scale designed to measure depression severity, and to detect changes due to antidepressant treatment. Scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of symptoms), summed for a total possible score of 0 to 60. Higher scores represent more severe condition. Missing data was imputed using LOCF method and last post baseline observation during the double-blind induction phase was carried forward as the End Point for that phase." (NCT02422186)
Timeframe: At Endpoint-Double-blind Induction Phase [Day 28]

InterventionPercentage of Participants (Number)
Intranasal Esketamine Plus Oral Antidepressant (AD)15.5
Oral AD Plus Intranasal Placebo6.3

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Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score up to Endpoint (Double-blind Induction Phase [Day 28])- Mixed-Effects Model Using Repeated Measures (MMRM) Analysis

The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items (to evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel [interest level], pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0-60. Higher scores represent a more severe condition. Negative change in score indicates improvement. (NCT02422186)
Timeframe: Baseline up to Endpoint (Double-blind Induction Phase[Day 28])

InterventionUnits on a scale (Mean)
Intranasal Esketamine Plus Oral Antidepressant (AD)-10.0
Oral AD Plus Intranasal Placebo-6.3

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Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score to Endpoint (Double-blind Induction Phase [Day 28])- Analysis of Covariance (ANCOVA) Analysis

"The MADRS is a clinician-rated scale designed to measure depression severity and to detect changes due to antidepressant treatment. The scale consists of 10 items (to evaluates apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel [interest level], pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0-60. Higher scores represent a more severe condition. Negative change in score indicates improvement. Missing data was imputed using Last Observation Carried Forward (LOCF) method and last post baseline observation during the double-blind induction phase was carried forward as the End Point for that phase." (NCT02422186)
Timeframe: Baseline and Endpoint (Double-blind Induction Phase [Day 28])

InterventionUnits on a scale (Mean)
Intranasal Esketamine Plus Oral Antidepressant (AD)-9.3
Oral AD Plus Intranasal Placebo-5.6

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Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) to Endpoint (Double-blind Induction Phase [Day 28]): Sum Score

"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 (health state value equal to dead) and 0.949 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT02422186)
Timeframe: Baseline and Endpoint (Double-blind Induction Phase [Day 28])

InterventionUnits on a scale (Mean)
Intranasal Esketamine Plus Oral Antidepressant (AD)-6.6
Oral AD Plus Intranasal Placebo-1.6

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Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) to Endpoint (Double-blind Induction Phase [Day 28]): Health Status Index

"EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a health status index (HSI). HSI ranges from -0.148 (health state value equal to dead) and 0.949 (full health), is anchored at 0 (dead) and 1 (full health)." (NCT02422186)
Timeframe: Baseline and Endpoint (Double-blind Induction Phase [Day 28])

InterventionUnits on a scale (Mean)
Intranasal Esketamine Plus Oral Antidepressant (AD)0.081
Oral AD Plus Intranasal Placebo0.026

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Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) to Endpoint (Double-blind Induction Phase [Day 28]): EQ-VAS

EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). (NCT02422186)
Timeframe: Baseline and Endpoint (Double-blind Induction Phase [Day 28])

InterventionUnits on a scale (Mean)
Intranasal Esketamine Plus Oral Antidepressant (AD)6.2
Oral AD Plus Intranasal Placebo4.4

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Change From Baseline in EuroQol-5 Dimension-5 Level (EQ-5D-5L) Sum Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from 0 (dead) to 1.00 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD7.5
Oral AD+ Intranasal Placebo10.9

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Change From Baseline in EuroQol-5 Dimension-5 Level Sum Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD3.0
Oral AD+ Intranasal Placebo8.4

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Change From Baseline in Sheehan Disability Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

The SDS is a participant-reported outcome measure and is a 5-item questionnaire used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1: work/school 2: social life 3: family life/home responsibilities using a 0-10 rating scale. It also has one item on days lost from school or work and one item on days when underproductive. The score for the first 3 items are summed to create a total score of 0-30 where a higher score indicates greater impairment. The recall period is 7 days. Scores <= 4 for each item and <= 12 for the total score are considered response. Scores <= 2 for each item and <= 6 for the total score are considered remission. The change from baseline in SDS total Score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD2.2
Oral AD+ Intranasal Placebo6.8

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Change From Baseline in Generalized Anxiety Disorder-7 Items (GAD-7) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21). Item responses are summed to yield a total score (range of 0 to 21), with higher scores indicating more anxiety. The change from baseline in GAD-7 total score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD2.2
Oral AD+ Intranasal Placebo4.0

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Change From Baseline in Generalized Anxiety Disorder-7 Items Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

GAD-7 is a brief and validated 7-item self-report assessment of overall anxiety. Participants respond to each item using a 4-point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15 -21). Item responses are summed to yield a total score (range of 0 to 21), with higher scores indicating more anxiety. The change from baseline in GAD-7 total score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD1.4
Oral AD+ Intranasal Placebo2.6

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Change From Baseline in MADRS Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal - severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. The change from baseline in MADRS total score (last observation carried forward [LOCF] data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD7.5
Oral AD+ Intranasal Placebo12.5

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Time to Relapse in Participants With Stable Remission (Maintenance Phase)

Relapse is defined as any of following: Montgomery-asberg depression rating scale (MADRS) total score greater than or equal to (>=) 22 for 2 consecutive assessments separated by 5-15 days and/or hospitalization for worsening depression or any other clinically relevant event to be suggestive of a relapse of depressive illness such as suicide attempt/completed suicide/hospitalization for suicide prevention; If hospitalized, start date of hospitalization will be date of relapse, if not hospitalized date of event will be used. MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal-severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. Stable remission: MADRS total score less than or equal to (<=) 12 for at least 3 of last 4 weeks of OP phase, with 1 excursion total score greater than (>) 12 or one missing assessment at OP week 13 or 14. (NCT02493868)
Timeframe: Time from randomization to the first relapse during the maintenance phase (up to 92 Weeks)

InterventionDays (Median)
Intranasal Esketamine + Oral ADNA
Oral AD+ Intranasal Placebo273.0

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Change From Baseline in MADRS Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal - severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. The change from baseline in MADRS total score (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD4.4
Oral AD+ Intranasal Placebo11.4

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Time to Relapse in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

Relapse is defined as any of following: MADRS total score >= 22 for 2 consecutive assessments separated by 5-15 days and/or hospitalization for worsening depression or any other clinically relevant event to be suggestive of a relapse of depressive illness such as suicide attempt/completed suicide/hospitalization for suicide prevention; If hospitalized, start date of hospitalization will be date of relapse, if not hospitalized date of event will be used. MADRS: clinician-rated scale to measure depression severity and to detect changes due to antidepressant treatment. It has 10 items, scored from 0-6 (not present/normal-severe/continuous symptoms), with total score of 60. Higher scores mean more severe condition. Stable response is defined as >= 50 percent (%) reduction in MADRS total score from baseline (Day 1 of induction phase, prior to first intranasal dose) in each of the last 2 weeks of the OP phase, but without meeting criteria for stable remission. (NCT02493868)
Timeframe: Time from randomization to the first relapse during the maintenance phase (up to 92 Weeks)

InterventionDays (Median)
Intranasal Esketamine + Oral AD635.0
Oral AD+ Intranasal Placebo88.0

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Change From Baseline in Patient Health Questionnaire-9 (PHQ-9) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

PHQ-9 is a 9-item, self-report scale assessing depressive symptoms. Each item is rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). The change from baseline in PHQ-9 total score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD3.3
Oral AD+ Intranasal Placebo5.9

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Change From Baseline in EQ-5D-5L Health Status Index at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

"EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health)." (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD-0.023
Oral AD+ Intranasal Placebo-0.073

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Change From Baseline in PHQ-9 Total Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

PHQ-9 is a 9-item, self-report scale assessing depressive symptoms. Each item is rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day). The participant's item responses are summed to provide a total score (range of 0 to 27) with higher scores indicating greater severity of depressive symptoms. The severity of the PHQ-9 is categorized as follows: None-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27). The change from baseline in PHQ-9 total score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD1.7
Oral AD+ Intranasal Placebo4.7

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Change From Baseline in Sheehan Disability Scale (SDS) Total Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

The SDS is a participant-reported outcome measure and is a 5-item questionnaire used and accepted for assessment of functional impairment and associated disability. The first 3 items assess disruption of 1: work/school 2: social life 3: family life/home responsibilities using a 0-10 rating scale. It also has one item on days lost from school or work and one item on days when underproductive. The score for the first 3 items are summed to create a total score of 0-30 where a higher score indicates greater impairment. The recall period is 7 days. Scores <= 4 for each item and <= 12 for the total score are considered response. Scores <= 2 for each item and <= 6 for the total score are considered remission. The change from baseline in SDS total Score, (LOCF data), at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD4.7
Oral AD+ Intranasal Placebo7.2

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Change From Baseline in EQ-5D-5L Health Status Index at Endpoint in Participants With Stable Remission (Maintenance Phase)

"EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from 0 (dead) to 1.00 (full health)." (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD-0.067
Oral AD+ Intranasal Placebo-0.096

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Change From Baseline in EQ-5D-5L EQ Visual Analogue Scale Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD-1.3
Oral AD+ Intranasal Placebo-13.8

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Change From Baseline in EQ Visual Analogue Scale Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

EQ-5D-5L is a 2-part instrument for use as a measure of health outcome, designed for self-completion by respondents. It consists of EQ-5D-5L descriptive system and EQ VAS. The EQ VAS self-rating records the respondent's own assessment of his or her overall health status at the time of completion, on a scale of 0 (the worst health you can imagine) to 100 (the best health you can imagine). (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Mean)
Intranasal Esketamine + Oral AD-10.4
Oral AD+ Intranasal Placebo-16.1

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Change From Baseline in Clinical Global Impression-Severity Score at Endpoint in Participants With Stable Response (But Not in Stable Remission) (Maintenance Phase)

CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The change from baseline in CGI-S score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Median)
Intranasal Esketamine + Oral AD0.0
Oral AD+ Intranasal Placebo1.0

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Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Endpoint in Participants With Stable Remission (Maintenance Phase)

CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The change from baseline in CGI-S score, (LOCF data) at endpoint was reported. The last post baseline observation was carried forward as the endpoint. (NCT02493868)
Timeframe: Baseline and Endpoint (Up to 92 Weeks)

InterventionUnits on a scale (Median)
Intranasal Esketamine + Oral AD0.0
Oral AD+ Intranasal Placebo1.0

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Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Recognition Discrimination Index

HVLT measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)

InterventionNumber of words (Mean)
Intranasal Esketamine + Oral Antidepressant0.5

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Change From Baseline in Sheehan Disability Scale (SDS) Total Score During IND Phase

"SDS was a 5 item questionnaire used for assessment of functional impairment and associated disability. The first three items assess disruption of (1) work/school, (2) social life, (3) family life/home responsibilities using a 0 to 10 rating scale. Score for the first three items are summed to create a total score of 0 to 30, higher score indicates greater impairment and a negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND Phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-9.3

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Change From Baseline in Sheehan Disability Scale Total Score During OP/MA Phase

"SDS was a participant-reported outcome measure and was a 5 item questionnaire used for assessment of functional impairment and associated disability. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0 to 10 rating scale. The score for the first three items are summed to create a total score of 0 to 30 where a higher score indicates greater impairment and a negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-1.6

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Change From Baseline to Endpoint in CGI-S Scale Score During OP/MA Phase

"The CGI-S measures the severity of the participant's illness that include knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 0 to 7, where 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)

InterventionUnits on a Scale (Median)
Intranasal Esketamine + Oral Antidepressant0.0

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Change From Baseline to Endpoint in Clinical Global Impression of Severity (CGI-S) Scale Score During IND Phase

"CGI-S measures severity of participant's illness that include knowledge of participant's history, psychosocial circumstances, symptoms, behavior, impact of symptoms on participant's ability to function. CGI-S evaluates severity of psychopathology on a scale range from 0 - 7, where 0=not assessed; 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as Endpoint." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)

InterventionUnits on a Scale (Median)
Intranasal Esketamine + Oral Antidepressant-2.0

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Percentage of Participants With an Increase Score From Predose at Any Time in CADSS Total Score During OP/MA Phase

"The CADSS used to measure present-state dissociative symptoms, and to assess treatment-emergent dissociative symptoms. It comprises 23 subjective items divided into 3 components: depersonalization (with score range from 0 to 28), derealization (with score range from 0 to 52), and amnesia (with score range from 0 to 8). Participants responses are coded on a 5-point scale (0 = Not at all, 1 = Mild, 2 = Moderate, 3 = 'Severe and 4 = Extreme). The total score is sum of the 23 items and range from 0 to 92, where 0 (best) and 92 (worst). A higher score indicates a more severe condition." (NCT02497287)
Timeframe: Predose, up to 1.5 hours postdose (up to end of OP/MA phase [Week 52])

InterventionPercentage of participants (Number)
Intranasal Esketamine + Oral Antidepressant86.1

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Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Total Recall

Hopkins Verbal Learning Test (HVLT) measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

InterventionNumber correct (Mean)
Intranasal Esketamine + Oral Antidepressant2.8

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Percentage of Participants With an Increase Score From Predose at Any Time in Clinician-Administered Dissociative States Scale (CADSS) Total Score During IND Phase

"The CADSS used to measure present-state dissociative symptoms, and to assess treatment-emergent dissociative symptoms. It comprises 23 subjective items divided into 3 components: depersonalization (with score range from 0 to 28), derealization (with score range from 0 to 52), and amnesia (with score range from 0 to 8). Participants responses are coded on a 5-point scale (0 = Not at all, 1 = Mild, 2 = Moderate, 3 = 'Severe and 4 = Extreme). The total score is sum of the 23 items and range from 0 to 92, where 0 (best) and 92 (worst). A higher score indicates a more severe condition." (NCT02497287)
Timeframe: Predose, up to 1.5 hours postdose (up to end of IND phase [Week 4])

InterventionPercentage of participants (Number)
Intranasal Esketamine + Oral Antidepressant92.0

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Percentage of Participants With Treatment-Emergent Acute Hypertension (Systolic and Diastolic) During IND and OP/MA Phases

Percentage of participants with treatment-emergent acute hypertension (Systolic Blood Pressure >=180 millimeters of mercury [mm Hg] or Diastolic Blood Pressure >= 110 mm Hg) during IND and OP/MA Phases were evaluated. (NCT02497287)
Timeframe: Up to End of OP/MA phase (Week 52)

InterventionPercentage of participants (Number)
Systolic BP >=180Diastolic BP >=110Acute hypertension
Intranasal Esketamine + Oral Antidepressant2.22.44.1

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Change From Baseline in Cognitive Test Battery: Groton Maze Learning Test (GMLT) Score

This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. GMLT measures executive function; maze/sequencing test, scored for total number of errors. Total score ranges from 0 to 999 number of errors. Lower score indicates better performance. Higher change from baseline indicates better performance. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

InterventionNumber of Errors (Mean)
Intranasal Esketamine + Oral Antidepressant6.9

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Change From Baseline in Cognitive Test Battery: Detection Test (DET) Score

This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. The DET is a measure of psychomotor function and uses a well-validated simple reaction time. In this outcome measure, speed of performance of participants (calculated as mean of the logarithmic base 10 transformed reaction times) for correct responses was reported. Total score ranges from 2 to 3.3 log 10 milliseconds (msec). Lower score indicates better performance. Higher change from baseline indicates better performance. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of Optimization/Maintenance [OP/MA] Phase)

Interventionlog10 msec (Mean)
Intranasal Esketamine + Oral Antidepressant-0.0028

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Percentage of Participants With Response as Assessed by PHQ-9 Total Score During IND Phase

"Response is defined as >= 50 % reduction from baseline (IND phase) in PHQ-9 total score. PHQ-9 is a 9-item, self-reporting scale assessing depressive symptoms. Each item was rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day), with a total score range of 0-27. The scores are summed for a total score ranging from 0-27. A higher score indicates greater severity of depression. Severity of PHQ-9 categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). The recall period is 2 weeks. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Day 15 and Endpoint (last post-baseline assessment value during 4 Week IND phase)

InterventionPercentage of participants (Number)
Day 15End point
Intranasal Esketamine + Oral Antidepressant37.262.0

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Percentage of Participants With Response as Assessed by MADRS Total Score During IND Phase

"Response is defined as greater than or equal to (>=) 50 % reduction from baseline in the MADRS total score. MADRS measures depression severity, detects changes due to AD treatment. It consists 10 items (evaluate apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores indicate more severe condition. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Days 8, 15, 22 and Endpoint (last post-baseline assessment during 4 weeks of IND phase)

InterventionPercentage of participants (Number)
Day 8Day 15Day 22End point
Intranasal Esketamine + Oral Antidepressant11.625.042.878.4

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Percentage of Participants With Remission as Assessed by PHQ-9 Total Score During IND Phase

"Remission is defined as PHQ-9 total score <= 4. PHQ-9 is a 9-item, self-reporting scale assessing depressive symptoms. Each item was rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day), with a total score range of 0-27. The scores are summed for a total score ranging from 0-27. A higher score indicates greater severity of depression. severity of PHQ-9 categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). The recall period is 2 weeks. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Day 15 and Endpoint (last post-baseline assessment value during 4 weeks of IND phase)

InterventionPercentage of participants (Number)
Day 15Endpoint
Intranasal Esketamine + Oral Antidepressant12.726.9

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Percentage of Participants With Remission as Assessed by MADRS Total Score During IND Phase

"Remission is defined as MADRS total score less than or equal to (<=) 12. MADRS measures depression severity, detects changes due to AD treatment. It consists 10 items (evaluate apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores indicate more severe condition. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Days 8, 15, 22 and Endpoint (last post-baseline assessment value during 4 weeks of IND Phase)

InterventionPercentage of participants (Number)
Day 8Day 15Day 22End point
Intranasal Esketamine + Oral Antidepressant7.315.627.247.2

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Percentage of Participants With Cystitis, Urinary Tract Infections, Renal and Urinary Tract Symptoms, Renal and Urinary Disorders

"Percentage of participants with cystitis, urinary tract infections, renal and urinary tract symptoms, renal and urinary disorders were evaluated. Cystitis and urinary tract infections are selected MedDRA preferred terms, renal and urinary tract symptoms refers to any preferred term (PT) in the group of selected PTs; and renal and urinary disorders refers to a MedDRA System Organ Class (SOC)." (NCT02497287)
Timeframe: Up to End of Follow up Phase (Week 56)

InterventionPercentage of participants (Number)
CystitisUrinary tract infectionsRenal and urinary disordersRenal and urinary tract symptoms
Intranasal Esketamine + Oral Antidepressant0.68.110.517.0

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Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)

An adverse event is any untoward medical occurrence in a clinical study participants who administered a medicinal (investigational or non-investigational) product and does not necessarily have a causal relationship with the treatment. A TEAE defined as an event that was new in onset or increased in severity following treatment initiation. (NCT02497287)
Timeframe: Up to End of Follow up Phase (Week 56)

InterventionPercentage of participants (Number)
Intranasal Esketamine + Oral Antidepressant90.1

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Change From Baseline to Endpoint in EQ-5D-5L Scale Score During IND Phase: Health Status Index

"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health)." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant0.190

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Change From Baseline to Endpoint in EQ-5D-5L Scale Score During OP/MA Phase: Health Status Index

"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a HSI. HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health)." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-0.009

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Change From Baseline to Endpoint in EQ-5D-5L Score During IND Phase: EQ-VAS

EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant17.0

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Change From Baseline to Endpoint in EQ-5D-5L Score During OP/MA Phase: EQ-VAS

EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant1.6

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Change From Baseline to Endpoint in European Quality of Life (EuroQol) 5-Dimension, 5-Level (EQ 5D-5L) During IND Phase: Sum Score

"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-15.3

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Change From Baseline to Endpoint in European Quality of Life (EuroQol) 5-Dimension, 5-Level (EQ 5D-5L) During OP/MA Phase: Sum Score

"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ VAS. EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health). EQ VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-0.7

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Change From Baseline to Endpoint in GAD-7 Total Score During OP/MA Phase

"GAD-7 is brief and validated 7-item self-reported assessment of overall anxiety. Participants respond to each item using a 4 point scale with response categories: 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score ranges from 0 to 21, higher scores indicate more anxiety. Negative change in score indicates improvement. Severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14), Severe (15 -21). Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant0.2

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Change From Baseline to Endpoint in Generalized Anxiety Disorder (GAD-7) Total Score During IND Phase

"GAD-7 is brief, validated 7-item self-reported assessment of overall anxiety. Participant's responded to each item using a 4 point scale with response categories: 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield total score ranges from 0 to 21, higher scores indicate more anxiety. Negative change in score indicates improvement. Severity of GAD-7 is categorized as: None (0-4), Mild (5-9), Moderate (10-14), Severe (15 -21). Missing data was imputed using LOCF method, last post baseline observation during the phase was carried forward as Endpoint." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-5.9

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Change From Baseline to Endpoint in PHQ-9 Total Score During OP/MA Phase

"PHQ-9 is a 9-item, self-reporting scale assessing depressive symptoms. Each item was rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day), with a total score range of 0-27. A higher score indicates greater severity of depression. severity of PHQ-9 categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). The recall period is 2 weeks. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-0.2

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Change From Baseline to Endpoint in MADRS Total Score During Optimization/Maintenance (OP/MA) Phase

"MADRS measure depression severity, detects changes due to AD treatment. It evaluates 10 items: apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts, each of which is scored from 0 (item is not present or is normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores represent a more severe condition. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (OP/MA) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant0.3

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Change From Baseline to Endpoint in Montgomery Asberg Depression Rating Scale (MADRS) Total Score During Induction (IND) Phase

"MADRS measures depression severity, detects changes due to AD treatment. It consists 10 items (evaluate apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, interest level, pessimistic thoughts, suicidal thoughts), scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score of 0 to 60. Higher scores indicate more severe condition. Negative change in score indicates improvement. Missing data was imputed using last observation carried forward (LOCF) method, last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-16.4

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Change From Baseline to Endpoint in Patient Health Questionnaire - 9 (PHQ-9) Total Score During IND Phase

"PHQ-9 is a 9-item, self-reporting scale assessing depressive symptoms. Each item was rated on a 4-point scale (0 = Not at all, 1 = Several Days, 2 = More than half the days, and 3 = Nearly every day), with a total score range of 0-27. A higher score indicates greater severity of depression. Severity of PHQ-9 categorized as follows: none-minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), severe (20-27). The recall period is 2 weeks. Negative change in score indicates improvement. Missing data was imputed using LOCF method and the last post baseline observation during the phase was carried forward as the Endpoint." (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 4 weeks of IND phase)

InterventionUnit on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant-8.9

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Change From Baseline in Cognitive Test Battery: Identification Test (IDN) Score

This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. IDN test is a measure of visual attention (choice reaction time) and scored for speed of response (mean of the log10 transformed reaction times for correct responses). Total score ranges from 2 to 3.3 log 10 msec. Lower score indicates better performance. Higher change from baseline indicates better performance. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

Interventionlog10 msec (Mean)
Intranasal Esketamine + Oral Antidepressant-0.0083

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Change From Baseline in Cognitive Test Battery: One Back Test (ONB) Score

The ONB is a measure of working memory and scored for speed of correct response (mean of the log10-transformed reaction times for correct responses). Total score ranges from 2 to 3.54 log10 msec. Lower score indicates better performance. Higher change from baseline indicates better performance. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

Interventionlog10 msec (Mean)
Intranasal Esketamine + Oral Antidepressant0.0177

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Change From Baseline in Cognitive Test Battery: One Card Learning Test (OCL) Score

This battery is a series of computerized cognition tests (detection, identification, one card learning, one back and groton maze learning) designed to measure reaction time, visual learning and memory, and executive function/sequencing. OCL test is a measure of visual episodic memory and visual recall test scored using arcsine transformation of the percentage of correct responses (CR). The range for OCL is 0 to 100 percent (%) accuracy; presented as an arcsin transformation, the range is 0 to 1.57. Higher score indicates better performance. Higher change from baseline indicates better performance. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

InterventionArcsine ([sqrt] of proportion of [CR]) (Mean)
Intranasal Esketamine + Oral Antidepressant0.0502

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Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Delayed Recall

HVLT measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

InterventionNumber correct (Mean)
Intranasal Esketamine + Oral Antidepressant0.8

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Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) Score: Number of Words Recalled

HVLT measures performance in verbal memory, learning, and long-term recall in which a list of words is read up to three times. Approximately 20-25 minutes later, a delayed recall trial and a recognition trial are completed. The delayed recall requires free recall of any words remembered. The recognition trial is composed of 24 words, including the 12 target words and 12 false-positives. When scoring the HVLT, the three learning trials are combined to calculate a total recall score (0-36); the delayed recall trial creates the delayed recall score (0 -12); the retention (%) score (0-100%) is calculated by dividing the delayed recall trial by the higher of learning trial 2 or 3; and the recognition discrimination index is comprised by subtracting the total number of false positives from the total number of true positives. A higher score = higher cognition. (NCT02497287)
Timeframe: Baseline (IND) up to the Endpoint (last post-baseline assessment value during 52 weeks of OP/MA Phase)

InterventionNumber of words recalled (Mean)
Intranasal Esketamine + Oral Antidepressant0.3

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Change in Baroreflex Sensitivity, ms/mm Hg

To assess baroreflex sensitivity (BRS), beat-by-beat systolic blood pressure (SBP) and heart rate (HR) were collected using the Nexfin noninvasive BP monitor (Bmeye, Amsterdam, Netherlands). BRS was estimated from the magnitude of the transfer function relating R-R interval oscillations to SBP oscillations across the 0.07 to 0.1299 Hz, or low frequency band. (NCT02516332)
Timeframe: Baseline, 3 months

Interventionms/mm Hg (Least Squares Mean)
Supervised Aerobic Exercise1.2
Lexapro1.3
Placebo1.5

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Change in Heart Rate Variability, SDNN (Msec)

To quantify heart rate variability (HRV), an electrocardiogram was recorded for 24-hours using the 3-channel DigiTrak XT Holter recorder (Philips Healthcare, Andover, Massachusetts). Electrocardiographic data were downloaded and edited using the Philips Zymed Holter analysis software (2010 Plus/1810 series) and HRV was estimated from the standard deviation of the normal-to-normal R-R intervals (SDNN). (NCT02516332)
Timeframe: Baseline, 3 months

Interventionmsec (Least Squares Mean)
Supervised Aerobic Exercise-0.3
Lexapro-8.7
Placebo-1.1

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Change in Hospital Anxiety and Depression Scale (HADS), Anxiety

The Hospital Anxiety and Depression Scale, Anxiety, is a 7-item subscale with scores ranging from 0-21, with higher scores indicating more anxiety. (NCT02516332)
Timeframe: Baseline, 3 months

Interventionscore on a scale (Least Squares Mean)
Supervised Aerobic Exercise-3.9
Lexapro-5.7
Placebo-3.5

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Change in Inflammation (C-Reactive Protein, ug/ml)

High-sensitivity C-reactive protein was quantified by ELISA (LabCorp). Values >10 mg/L were truncated at 10 to account for acute inflammatory processes that may have skewed the distribution of this blood marker. (NCT02516332)
Timeframe: Baseline, 3 months

Interventionug/ml (Least Squares Mean)
Supervised Aerobic Exercise-0.2
Lexapro0.1
Placebo-0.3

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Change in Urinary Catecholamines (Epinephrine and Norepinephrine, Unit-weighted Z-score)

Urinary catecholamines, an index of sympathetic nervous system (SNS) activity, served as a biomarker of anxiety. Urinary concentrations of epinephrine (EPI) and norepinephrine (NE) were determined by high-pressure liquid chromatography (HPLC) with electrochemical detection (LabCorp). A composite 24-hr catecholamines z-score is presented. The z-score is the raw score minus the population mean, divided by the population standard deviation. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. (NCT02516332)
Timeframe: Baseline, 3 months

Interventionz-score (Least Squares Mean)
Supervised Aerobic Exercise0.05
Lexapro-0.24
Placebo0.36

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Change in Vascular Endothelial Function, Percentage of Dilation

Endothelial function, assessed by Flow-Mediated Dilation (FMD), was determined from longitudinal B-mode ultrasound images of the brachial artery. Images were obtained using an Acuson (Mountain View, California) Aspen ultrasound platform with an 11-MHz linear-array transducer after 10 min of supine relaxation and during reactive hyperemia, induced by the inflation of a forearm pneumatic occlusion cuff to suprasystolic pressure (about 200 mm Hg) and subsequent deflation after 5 min. FMD was defined as the maximum percentage change in arterial diameter relative to resting baseline from 10 to 120 s after deflation of the occlusion cuff. (NCT02516332)
Timeframe: Baseline, 3 months

Interventionpercentage of dilation (Least Squares Mean)
Supervised Aerobic Exercise0.7
Lexapro0.5
Placebo0.5

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Change in Lipids - Total Cholesterol, LDL (Low-density Lipoprotein), and HDL (High-density Lipoprotein); mg/dL

Lipids were obtained from fasting blood samples and assays were measured enzymatically (LabCorp). (NCT02516332)
Timeframe: Baseline, 3 months

,,
Interventionmg/dL (Least Squares Mean)
Total CholesterolLDLHDL
Lexapro-15.3-9.83.4
Placebo-31.6-19.37.2
Supervised Aerobic Exercise-28.2-18.66.3

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Change of Mean Score of the Behavioral Health Measure-20 Between Baseline and End of Study

The Behavioral Health Measure - 20 (BHM-20) is a 20-item client-report questionnaire that assesses the three phases of behavioral health: (a) well-being (distress, life satisfaction, motivation), (b) psychological symptoms (depression, anxiety, panic disorder, mood swings associated with bipolar disorder, eating disorder, alcohol/drug abuse, suicidality, risk of violence), and (c) life functioning (work/school, intimate relationships, social relationships, life enjoyment). The BHM-20 assesses the most frequently seen problems in outpatient psychotherapy. Scores range from 0-4. Lower scores indicate more distress. (NCT02579343)
Timeframe: Assessed at Baseline and After Treatment, Approximately 6 Weeks later.

Interventionunits on a scale (Mean)
Auricular Acupuncture + Lexipro0.89
Sham Auricular Acupuncture + Lexapro0.47

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Change From Baseline Score of the Sheehan Disability Scale Through 6 Weeks

Instrument developed to assess functional impairment in three inter-related domains; work/school, social and family life. Items are scored on a 0 - 10 point scale. Higher scores indicate more functional impairment. (NCT02579343)
Timeframe: Assessed at baseline and 6 weeks.

,
Interventionunits on a scale (Mean)
Work / School DomainSocial Life DomainFamily Life Domain
Auricular Acupuncture + Lexipro-3.57-2.29-3.42
Sham Auricular Acupuncture + Lexapro-1.5-1.0-0.17

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Quantification of Brain MRGlu Without an Arterial Catheter by Training Simultaneous Estimation (SimE)

Using Simultaneous Estimation, we imputed the arterial input function from a single venous sample. When we compared the resulting imputed arterial input function to the actual arterial input function collected from plasma samples, we calculated the percent difference in activity and report it here. (NCT02623205)
Timeframe: Baseline

InterventionPercent of Activity (Mean)
Mixed2.0

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Correlation Coefficient of VersaPET Scanner From Measurements Taken at the Wrist or Ankle

Arterial measurements from samples taken at the wrist were compared to the values from the VersaPET scanner (at the ankle) where the correlation coefficient between the scanner and arterial sampling are being reported. Correlation coefficient ranges from -1 to 1. The closer the value is to 1, the higher the correlation or stronger the relationship. (NCT02623205)
Timeframe: Baseline

InterventionCorrelation Coefficient (Number)
Mixed0.97

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Change From Baseline in Metabolic Rate of Glucose (MRGlu), Quantified Using Arterial Blood Analysis, at 8 Weeks

Difference between MRGlu Metabolism in Right Insular Cortex before treatment (baseline) and after treatment (week 8). Details on methods and criteria used to assess brain glucose metabolism rates can be found here: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8551925/ (NCT02623205)
Timeframe: 8 weeks

Interventionmg/(min*100 ml) (Mean)
Escitalopram0.507489448
Placebo0.068629964

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Change From Baseline in Hamilton Depression Rating Scale at 8 Weeks

"Comparison of Hamilton Depression Rating Scale-17 score at pretreatment and post-treatment.~Minimum score 0, maximum possible score 52, with remission defined as <=7. The higher the score on the scale, the more severe the degree of depression." (NCT02623205)
Timeframe: 8 weeks

Interventionscore on a scale (Mean)
Escitalopram11.81
Placebo9.41

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Bias of VersaPET Scanner From Measurements Taken at the Wrist and Ankle

Our goal was to determine the Bias of plasma radioactivity measurements taken at the ankle with a Novel Positron Emission Tomography (VersaPET) Scanner compared to radioactivity from arterial sampling taken at the wrist. Bias refers to the offset between the ground truth and estimated data. A bias of 0% is ideal. (NCT02623205)
Timeframe: Baseline

InterventionPercent (Number)
Mixed5

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Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Scores

The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. It was designed in 1979 by British and Swedish researchers as an adjunct to the Hamilton Rating Scale for Depression (HAMD) which would be more sensitive to the changes brought on by antidepressants and other forms of treatment than the Hamilton Scale was.[2] There is, however, a high degree of statistical correlation between scores on the two measures. (NCT02674529)
Timeframe: baseline and week 8

Interventionscore on a scale (Mean)
Changes in MADRS Scores From Baseline to Week 8 Within the Antidepressant Treatment Arm11
Changes in MADRS Scores From Baseline to Week 8 Within the Placebo Arm12

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Neural Responses During the Sham Neurofeedback fMRI Task.

Voxel-wise BOLD changes during the expectancy condition of the Sham Neurofeedback fMRI task. (NCT02674529)
Timeframe: Baseline

InterventionBOLD signal change (Mean)
Baseline fMRI Measures1.1

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Change in Quick Inventory of Depressive Symptomatology (QIDS) Scores

The Quick Inventory of Depressive Symptomatology (QIDS) is a 16-item, self-reported measure of depression that ranges from 1 (no depression) to 27 (very severe depression). (NCT02674529)
Timeframe: baseline and 8 weeks

Interventionscore on a scale (Mean)
Changes in QIDS Scores From Baseline to Week 8 Within the Antidepressant Treatment Arm6.82
Changes in QIDS Scores From Baseline to Week 8 Within the Placebo Arm5.54

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Social Adjustment Scale Self-Report (SAS-SR) Score

"The SAS-SR contains 54 questions that measure instrumental and expressive role performance over the past 2 weeks. Each question is rated on a 5-point scale. The overall adjustment score is obtained by summing the scores of all the items and dividing by the number of items answered.~The SAS-R overall score ranges from 0-270, with higher questions indication more impairment." (NCT03321006)
Timeframe: 12 weeks

Interventionscore on a scale (Mean)
Antidepressant (AD) + Low Amplification (Sham) Hearing Aids1.96
Antidepressant (AD) + Full Amplification Hearing Aids2.10

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Hamilton Rating Score for Depression (HRSD)

The patient is rated by a clinician among 24 dimensions (24-item HRSD) with a score on a 3 or 5 point scale. Maximum score is a 74. 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression. (NCT03321006)
Timeframe: 12 weeks

Interventionscore on a scale (Mean)
Antidepressant (AD) + Low Amplification (Sham) Hearing Aids12.04
Antidepressant (AD) + Full Amplification Hearing Aids13.86

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Clinical Global Impression Severity and Improvement (CGI)

Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale (range 0-7) that requires the clinician to rate the severity of the patient's illness at the time of assessment: range is from 0 (=normal, not at all ill) to 7 (=extremely ill, among the most extremely ill patients worsening) (NCT03321006)
Timeframe: 12 weeks

Interventionscore on a scale (Mean)
Antidepressant (AD) + Low Amplification (Sham) Hearing Aids3.17
Antidepressant (AD) + Full Amplification Hearing Aids3.20

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Adherence Consistency

To determine whether RT2CK17 + escitalopram results in greater consistency of adherence relative to placebo + escitalopram as measured by percentage of doses taken on schedule within 25% of the expected time interval, defined as +/- 6 hours from the participant's breakfast time (NCT03388164)
Timeframe: 8 weeks

Interventionpercentage of pills taken on time (Mean)
Escitalopram + RT2CK1789.8
Escitalopram + Placebo93.6

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Rate of Adherence

To determine whether RT2CK17 + escitalopram results in higher rates of medication adherence relative to placebo + escitalopram as measured by percentage pill count (NCT03388164)
Timeframe: 8 weeks

Interventionpercentage of pills taken (Mean)
Escitalopram + RT2CK1793.5
Escitalopram + Placebo97.6

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Change From Baseline in Clinical Global Impression Severity (CGI-S) Scale Score up to the Endpoint (Double-blind Treatment Phase [Day 28])

The CGI-S provides an overall clinician-determined summary measure of the severity of the participant's illness that takes into account all available information, including knowledge of the participant's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the participant's ability to function. The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating according to: 1=normal (not at all ill); 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients. The CGI-S permits a global evaluation of the participant's condition at a given time. Negative change in score indicates improvement. The last post-baseline observation during the double-blind phase was carried forward as Endpoint. (NCT03434041)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)

InterventionUnits on a Scale (Median)
Intranasal Esketamine + Oral Antidepressant (AD)-1.0
Intranasal Placebo + Oral AD-1.0

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Change From Baseline in Depressive Symptoms as Measured by the MADRS Total Score to 24 Hours Post First Dose (Day 2)

The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0 to 60. Higher scores represent a more severe condition. Negative change in score indicates improvement. (NCT03434041)
Timeframe: Baseline (Day 1: predose) to 24 hours post first dose (Day 2)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant (AD)-8.0
Intranasal Placebo + Oral AD-4.4

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Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score to the End of Double-blind Treatment Phase (Day 28)

The MADRS is a clinician-rated scale designed to measure depression severity and detects changes due to antidepressant treatment. The scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0 to 60. Higher scores represent a more severe condition. Negative change in score indicates improvement. (NCT03434041)
Timeframe: Baseline up to end of the double-blind treatment phase (Day 28)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant (AD)-10.1
Intranasal Placebo + Oral AD-8.1

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Change From Baseline in Participant-Reported Health Status as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) Score up to the Endpoint (Double-blind Treatment Phase [Day 28]): Visual Analogue Scale (VAS)

The EQ-5D-5L is a standardized 2-part instrument for use as a measure of health outcome, primarily designed for self-completion by respondents. It essentially consists of the EQ-5D-5L descriptive system and the EQ-VAS. EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Positive change in score indicates improvement. (NCT03434041)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant (AD)16.7
Intranasal Placebo + Oral AD11.9

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Change From Baseline in Participant-Reported Health Status as Assessed by EuroQol-5 Dimension-5 Level (EQ-5D-5L) up to the Endpoint (Double-blind Treatment Phase [Day 28]): Sum Score

"EQ-5D-5L consists of EQ-5D-5L descriptive system and EQ visual analogue scale (EQ-VAS). EQ-5D-5L descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). Participant selects answer for each of 5 dimensions considering response that best matches his/her health today. Responses were used to generate a Health Status Index (HSI). HSI ranges from -0.148 to 0.949 and is anchored at 0 (health state value equal to dead) and 1 (full health). EQ-VAS self-rating records the respondent's own assessment of his/her overall health status at time of completion, on a scale of 0 (worst health you can imagine) to 100 (best health you can imagine). Sum score ranges from 0 to 100 where, sum score = (sum of the scores from the 5 dimensions minus 5) *5. Higher score indicates worst health state." (NCT03434041)
Timeframe: Baseline up to Double-blind Endpoint (Day 28)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant (AD)-13.4
Intranasal Placebo + Oral AD-9.5

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Change From Baseline in Sheehan Disability Scale (SDS) Total Score to the End of Double-blind Treatment Phase (Day 28)

The SDS is a subject-reported outcome measure that consists of a 5-item questionnaire which has been widely used and accepted for assessment of functional impairment and associated disability. The first three items assess disruption of (1) work/school, (2) social life, and (3) family life/home responsibilities using a 0-10 rating scale. The score for the first three items are summed to create a total score of 0-30, where a higher score indicates greater impairment. It also has one item on days lost from school or work and one item on days when underproductive. (NCT03434041)
Timeframe: Baseline up to end of the double-blind treatment phase (Day 28)

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant (AD)-6.3
Intranasal Placebo + Oral AD-5.3

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Percentage of Participants in Remission at the End of Double-blind Treatment Phase (Day 28)

Percentage of participants in remission at the end of double-blind treatment phase (Day 28) were assessed. A participant was considered as a remitter if participant had a MADRS total score of less than or equal to [<=] 12 at a visit. MADRS scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0 to 60. Higher scores represent a more severe condition. Negative change in score indicates improvement. (NCT03434041)
Timeframe: Day 28

InterventionPercentage of Participants (Number)
Intranasal Esketamine + Oral Antidepressant (AD)12.8
Intranasal Placebo + Oral AD10.4

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Percentage of Participants With Onset of Clinical Response

Onset of clinical response is defined as greater than or equal to (>=) 50 percent (%) improvement from baseline in MADRS total score with onset by Day 2 that was maintained through Day 28. The MADRS scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0 to 60. Higher scores represent a more severe condition. Negative change in score indicates improvement. (NCT03434041)
Timeframe: Day 2 up to Day 28

InterventionPercentage of participants (Number)
Intranasal Esketamine + Oral Antidepressant (AD)6.5
Intranasal Placebo + Oral AD1.6

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Percentage of Participants With Sustained Remission

Sustained remission is defined as the first occurrence of remission (MADRS Total score <=12) that was maintained through the Day 28 assessment with one excursion prior to Day 28. The MADRS scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0 to 60. Higher scores represent a more severe condition. Negative change in score indicates improvement. (NCT03434041)
Timeframe: Up to Day 28

InterventionPercentage of Participants (Number)
Intranasal Esketamine + Oral Antidepressant (AD)5.6
Intranasal Placebo + Oral AD6.3

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Percentage of Responders at the End of Double-blind Treatment Phase (Day 28)

Percentage of responders at the end of double-blind treatment phase (Day 28) were assessed. A participant was defined as a responder at a given time point if the percent improvement from baseline in MADRS total score is at least 50%. The MADRS scale consists of 10 items (apparent sadness, reported sadness, inner tension, sleep, appetite, concentration, lassitude, inability to feel (interest level), pessimistic thoughts, and suicidal thoughts), each of which is scored from 0 (item not present or normal) to 6 (severe or continuous presence of the symptoms), summed for a total possible score range of 0 to 60. Higher scores represent a more severe condition. Negative change in score indicates improvement. (NCT03434041)
Timeframe: Day 28

InterventionPercentage of Responders (Number)
Intranasal Esketamine + Oral Antidepressant (AD)19.3
Intranasal Placebo + Oral AD16.0

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Change From Baseline in Generalized Anxiety Disorder 7-item (GAD-7) Scale Score up to the Endpoint (Double-blind Treatment Phase [Day 28])

"The GAD-7 is a brief and validated 7-item self-reported assessment of overall anxiety. Participants respond to each item using a 4 point scale with response categories of 0=not at all, 1=several days, 2=more than half the days, and 3=nearly every day. Item responses are summed to yield a total score with a range of 0 to 21, where higher scores indicate more anxiety. The recall period is 2 weeks. The severity of the GAD-7 is categorized as follows: None (0-4), Mild (5-9), Moderate (10-14) and Severe (15-21). The last post-baseline observation during the double-blind phase was carried forward as the Endpoint." (NCT03434041)
Timeframe: Baseline up to Endpoint (double-blind treatment phase [Day 28])

InterventionUnits on a Scale (Mean)
Intranasal Esketamine + Oral Antidepressant (AD)-4.3
Intranasal Placebo + Oral AD-2.9

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Efficacy - Anxiety Symptoms

Beck Anxiety Index (BAI) among those with high anxiety at baseline. The BAI is a self-report measure used for measuring the severity of anxiety. Scores range from 0 to 63, with a higher score representing more severe anxiety symptoms and higher scores representing worse outcomes. (NCT03464383)
Timeframe: baseline

Interventionscore on a scale (Mean)
Epileptologist-Driven Treatment18.0
Standard of Care10.5

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Adherence to Intervention

Percentage of participants who report taking the prescribed medication at 12 weeks and who have completed at least 2 of the chronic care management scheduled visits (telephone or clinic visit) (NCT03464383)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Epileptologist-Driven Treatment2
Standard of Care0
Survey Arm0

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Retention

Percentage of participants who complete the 12 week outcome assessment (NCT03464383)
Timeframe: 12 weeks

InterventionParticipants (Count of Participants)
Epileptologist-Driven Treatment2
Standard of Care2
Survey Arm0

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Efficacy - Depression Symptoms

Using Beck Depression Inventory-II (BDI-II) among those with high depression at baseline. The BDI-II is a self-report measure of depressive symptoms. Scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms and higher scores representing worse outcome. (NCT03464383)
Timeframe: baseline

Interventionscore on a scale (Mean)
Epileptologist-Driven Treatment26.7
Standard of Care21.0

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Efficacy - Depression Symptoms

Beck Depression Inventory-II (BDI-II) among those with high depression at baseline. The BDI-II is a self-report measure of depressive symptoms. Scores range from 0 to 63, with a higher score representing higher levels of depressive symptoms and higher scores representing worse outcome. (NCT03464383)
Timeframe: 12 weeks

Interventionscore on a scale (Mean)
Epileptologist-Driven Treatment25.0
Standard of Care17.0

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Accrual

Percentage of patients screened for the trial who are eligible (NCT03464383)
Timeframe: baseline

InterventionParticipants (Count of Participants)
Epileptologist-Driven Treatment Plus Standard of Care Arm19

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Efficacy - Anxiety Symptoms

Beck Anxiety Index (BAI) among those with high anxiety at baseline. The BAI is a self-report measure used for measuring the severity of anxiety. Scores range from 0 to 63, with a higher score representing more severe anxiety symptoms and higher scores representing worse outcomes. (NCT03464383)
Timeframe: 12 weeks

Interventionscore on a scale (Mean)
Epileptologist-Driven Treatment9.5
Standard of Care11

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Change From Baseline Hamilton Anxiety Rating Scale 14-item Scale

Scale for anxiety symptoms administered by trained rater. The Hamilton Anxiety is a standard measure of anxiety severity in pharmacotherapy studies that has been shown to have acceptable reliability and validity in studies of depressed patients. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. (NCT03812588)
Timeframe: Up to 8 Weeks

Interventionscore on a scale (Mean)
Clinical Frequency Management: Placebo3.67
Research Frequency Management: Placebo4.40
Clinical Frequency Management: Escitalopram6.50
Research Frequency Management: Escitalopram3.37

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Change From Baseline Clinical Global Impressions

"Scales developed to measure the clinician's view of subjects' global functioning before and after initiating a study medication. The Clinical Global Impressions correlates well with other standard outcome measures for depression (e.g., HRSD), is sensitive to change in antidepressant trials, and offers clinically understandable anchor points.~7-point scale: 0 = Not assessed 4 = Moderately ill~1 = Normal, not at all ill 5 = Markedly ill 2 = Borderline mentally ill 6 = Severely ill 3 = Mildly ill 7 = Among the most extremely ill patients" (NCT03812588)
Timeframe: Up to 8 Weeks

Interventionscore on a scale (Mean)
Clinical Frequency Management: Placebo1.00
Research Frequency Management: Placebo1.20
Clinical Frequency Management: Escitalopram0.67
Research Frequency Management: Escitalopram1.50

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Change From Baseline Hamilton Rating Scale for Depression 24-Item Scale to Study Completion (8 Weeks)

"Scale for depressive symptoms administered by trained rater. The Hamilton is the standard measure of depression severity for clinical trials of antidepressants and was chosen as the primary outcome measure over other depression rating scales to ensure compatibility of study results with our meta-analyses and ongoing studies of expectancy. The scoring is based on the first 24 items of the Hamilton.~Sum of the scores of the first 24 items (range from 0 to 74):~0-7 = NORMAL 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression >=23 = Very Severe Depression" (NCT03812588)
Timeframe: Up to 8 Weeks

Interventionscore on a scale (Mean)
Clinical Frequency Management: Placebo1.33
Research Frequency Management: Placebo11.4
Clinical Frequency Management: Escitalopram5.33
Research Frequency Management: Escitalopram9.25

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Change on the Children's Global Assessment Scale (CGAS)

Remission rate on the CGAS at acute treatment endpoint (Week 8). Functional remission is defined as CGAS >70. The CGAS used is a 100-point scale ranging from 1 to 100, with higher scores indicating better functioning. (NCT03924323)
Timeframe: Week 8

Interventionscore on a scale (Mean)
Placebo16.2
Escitalopram 10 mg/Day18.1

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Response Rate on the PARS

Response is defined as a 50% improvement on the PARS severity score for GAD (NCT03924323)
Timeframe: Week 8

InterventionParticipants (Count of Participants)
Placebo39
Escitalopram 10 mg/Day49

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Remission Rate on the PARS

Remission is defined as PARS severity score for GAD ≤8 (using 6 PARS items: 2, 3, 4, 5, 6, and 7) (NCT03924323)
Timeframe: Week 8

InterventionParticipants (Count of Participants)
Placebo22
Escitalopram 10 mg/Day22

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Change on the Clinical Global Impression of Severity (CGI-S)

Remission rate on CGI-S at acute treatment endpoint (Week 8). Remission rate is defined as the percentage of subjects having a CGI-S score ≤2 at endpoint. CGI-S is a seven point scale where 1=Normal and 7=Among the most extremely ill patients. (NCT03924323)
Timeframe: Week 8

Interventionscore on a scale (Mean)
Placebo-1.2
Escitalopram 10 mg/Day-1.3

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Change in Pediatric Anxiety Rating Scale (PARS) Severity Score

The PARS is a clinician-rated instrument for assessing the severity of anxiety symptoms associated with common anxiety disorders including generalized anxiety disorder (GAD) in children. The PARS severity score for GAD will be assessed for all symptoms identified in the generalized anxiety section of the PARS symptom checklist derived by summing 5 of the 7 severity/impairment/interference items (2, 3, 5, 6, and 7) each item ranged from 0 (none) to 5 (extreme severity/impairment/interference). PARS severity scores for GAD ranged from 0 (none) to 25 (extreme severity), with a score of 15 indicating moderate illness severity. (NCT03924323)
Timeframe: Baseline to Week 8

Interventionscore on a scale (Least Squares Mean)
Placebo-6.38
Escitalopram 10 mg/Day-7.81

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Hamilton Rating Scale for Depression

"17-item diagnostic questionnaire to measure the severity of depressive symptoms. The lowest possible score on the scale is 0 and the highest possible score is 52. The lowest possible score on the scale represents the lack of any depressive symptoms and the highest score represents the severe depressive symptoms." (NCT03927950)
Timeframe: The outcome was measured at the week 12

Interventionscore on a scale (Mean)
Escitalopram7.2

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Montgomery-Asberg's Depression Rating Scale

"Ten-item diagnostic questionnaire to measure the severity of depressive symptoms. The lowest possible score on the scale is 0 and the highest possible score is 60. The lowest possible score on the scale represents the lack of any depressive symptoms and the highest score represents the severe depressive symptoms." (NCT03927950)
Timeframe: the results are for a single time point (12 weeks)

Interventionscore on a scale (Mean)
Escitalopram Bupropion Open-label9.2

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Adverse Antidepressant Treatment Effects on CRP-consistent Antidepressant Selection Versus CRP-inconsistent Antidepressant Selection

Side effects will be assessed using the 3-item self-administered Frequency, Intensity, and Burden of Side Effects (FIBSER). Each item is scored on a scale from 0-6. Items 1 and 2 (Frequency & Intensity respectively) are to provide information to the clinician, but they are not used in the scoring.The score that is used comes only from Item 3 - Burden. Lower scores represents lower burden. (NCT03993457)
Timeframe: 1 year

Interventionscore on a scale (Mean)
CRP<1, CRP Consistent Antidepressant Selection.25
CRP> or Equal to 1, CRP Consistent Antidepressant Selection0
CRP<1, CRP Inconsistent Antidepressant Selection0
CRP> or Equal to 1, CRP Inconsistent Antidepressant Selection0

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Optional Sub-study. Validity and Reliability of Capillary Blood CRP Measurement

Capillary blood CRP levels will be compared with those obtained using venous blood obtained via venipuncture. Outcome will be number of participants whose capillary blood CRP levels and venous blood CRPT levels match in terms of <1 vs. >=1. (NCT03993457)
Timeframe: Baseline

InterventionParticipants (Count of Participants)
CRP<1, CRP Consistent Antidepressant Selection2
CRP> or Equal to 1, CRP Consistent Antidepressant Selection0
CRP<1, CRP Inconsistent Antidepressant Selection1
CRP> or Equal to 1, CRP Inconsistent Antidepressant Selection4

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Efficacy of CRP-consistent Antidepressant Selection Versus CRP-inconsistent Antidepressant Selection on Remission Rates in Patients With MDD.

The primary study endpoint will be remission rates based on the 16-items Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR), which will be extracted from the 30-item Inventory of Depressive Symptomatology (IDS-SR). The QIDS-SR score ranges from 0-27. A score of 5 or less represents remission. (NCT03993457)
Timeframe: 1 year

InterventionParticipants (Count of Participants)
CRP<1, CRP Consistent Antidepressant Selection3
CRP> or Equal to 1, CRP Consistent Antidepressant Selection1
CRP<1, CRP Inconsistent Antidepressant Selection1
CRP> or Equal to 1, CRP Inconsistent Antidepressant Selection2

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Efficacy of CRP-consistent Antidepressant Selection Versus CRP-inconsistent Antidepressant Selection on Improving Social and Occupational Functioning.

Improvement in social and occupational functioning will be measured with the 5-item self-administered Work and Social Adjustment Scale (WSAS). The WSAS total score ranges from 0-40. Lower scores are better. (NCT03993457)
Timeframe: 12 weeks

Interventionscore on a scale (Mean)
CRP<1, CRP Consistent Antidepressant Selection-17.3
CRP> or Equal to 1, CRP Consistent Antidepressant Selection-24.4
CRP<1, CRP Inconsistent Antidepressant Selection-18.0
CRP> or Equal to 1, CRP Inconsistent Antidepressant Selection-23.5

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Snaith-Hamilton Pleasure Scale (SHAPS-C) Score

The SHAPS-C is a 14-item clinician-administered scale assessing the amount of pleasure during common daily activities that the participant has experienced in the past week. Responses are given on a scale of 1 to 4 where 1 = lots of pleasure and 4 = no pleasure. Total scores range from 14 to 56 with lower scores indicating greater enjoyment of activities. (NCT04352101)
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8

,
InterventionScore on a scale (Mean)
BaselineWeek 2Week 4Week 6Week 8
Bupropion39.40036.22233.77835.37532.125
Escitalopram38.62533.37527.25025.25024.857

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Proportion of Hard-Task Choices During the Effort-Expenditure for Rewards Task (EEfRT)

The Effort-Expenditure for Rewards Task (EEfRT) is a computer-based multi-trial game to assess motivation. Participants are given an opportunity to choose different task difficulty levels to obtain monetary rewards (easy tasks have low rewards while hard tasks have higher rewards). Each trial has a high, medium, or low probability of success, and this information is given to the participant when they are deciding between easy and hard tasks. The task lasts for 20 minutes, and first 50 trials are analyzed. The proportion of hard-task choices across each level of probability is calculated. Possible values range between 0 to1 with 1 being a better outcome indicating the mean probability of making a hard (high effort) choice. Lower proportions of hard task choices indicate decreased motivation. (NCT04352101)
Timeframe: Baseline, Week 2, Week 4, Week 8

,
Interventionproportion of hard-task choices (Mean)
BaselineWeek 2Week 4Week 8
Bupropion0.3920.4500.3480.360
Escitalopram0.4500.3850.3210.323

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Motivation and Pleasure Scale-Self-Report (MAP-SR) Score

The MAP-SR is an 18-item self-report inventory that has been validated in psychiatric populations and is designed to disentangle motivational and consummatory components of everyday activities over a 24-hr period. Responses are given on a 5-point scale where 0 = no pleasure or motivation and 4 = extreme pleasure or motivation. Total scores range from 0 to 72 and higher scores indicate greater motivation and pleasure during everyday activities. (NCT04352101)
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8

,
InterventionScore on a scale (Mean)
BaselineWeek 2Week 4Week 6Week 8
Bupropion27.80029.33335.25037.25038.000
Escitalopram28.00034.87542.50044.75045.714

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Inventory of Depressive Symptomatology - Self-Report (IDS-SR)

The IDS-SR is a 30-item self-reported measurement of depression severity. Responses are given on a 4-point scale where 0 = no problems and 3 = severe problems. Total scores are based on 28 items and range from 0 to 84 with higher scores indicating more severe symptoms of depression. (NCT04352101)
Timeframe: Baseline, Week 2, Week 4, Week 6, Week 8

,
InterventionScore on a scale (Mean)
BaselineWeek 2Week 4Week 6Week 8
Bupropion38.80030.22223.55625.00023.875
Escitalopram42.25030.25021.50016.25018.143

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Change in Targeted Ventromedial Prefrontal Cortex-Ventral Striatal (vmPFC-VS) Functional Connectivity (FC)

Targeted FC is calculated as the degree of correlation in activity between a 3mm3 radius sphere in VS and the vmPFC cluster identified as being reward-sensitive in neuroimaging meta-analyses and as used to define vmPFC in previous work. Subject-level correlations for degree of vmPFC-VS FC is Fisher's Z transformed {Z(R)=0.5ln[(1+R)/(1-R)]}, a standard method for calculating fMRI functional connectivity, whereby greater Z-scores reflected stronger correlated functional magnetic resonance imaging (fMRI) activity (i.e., higher VS-vmPFC connectivity). For each study timepoint, Z-scores will be extracted and the change in mean FC values compared to baseline will be calculated. The central value is 0, and the standard deviation depends on the sample variance. Increasing values indicate increasing connectivity between the indicated brain regions (VS and vmPFC). There are no relevant thresholds, and there is no direct interpretation of results in terms of clinical improvement. (NCT04352101)
Timeframe: Baseline, Week 4, Week 8

,
InterventionZ-score (Mean)
Baseline to Week 4Baseline to Week 8
Bupropion0.020.02
Escitalopram-0.130.09

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Percentage of Participants With TEAEs, Graded by Severity

An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE was defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. The severity was graded as mild, moderate and severe. (NCT04476030)
Timeframe: Up to approximately 58 weeks

,
Interventionpercentage of participants (Number)
MildModerateSevere
Placebo + Assigned ADT38.125.22.3
SAGE-217 + Assigned ADT35.834.43.8

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Change From Baseline in CGI-S Score at Day 15

The CGI-S uses a 7-point Likert scale to rate the severity of the participant's illness at the time of assessment, relative to the clinician's past experience with participants who have the same diagnosis. Considering total clinical experience, the investigator rated the participant on severity of mental illness at the time of rating as: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; and 7 = extremely ill. A higher score indicated extreme illness. A negative change from baseline indicated improvement. LS mean was estimated using MMRM analysis. (NCT04476030)
Timeframe: Baseline and Day 15

Interventionscore on a scale (Least Squares Mean)
Active Comparator: Placebo + Assigned ADT-1.7
Experimental: SAGE-217 + Assigned ADT-1.9

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Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)

An adverse event (AE) was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal (investigational) product whether or not related to the medicinal (investigational) product. A TEAE was defined as an AE with onset after the start of IP, or any worsening of a pre-existing medical condition/AE with onset after the start of IP and throughout the study. (NCT04476030)
Timeframe: Up to approximately 58 weeks

Interventionpercentage of participants (Number)
Placebo + Assigned ADT65.6
SAGE-217 + Assigned ADT74.1

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Percentage of Participants With MADRS Response at Day 15

MADRS response was defined as having a 50% or greater reduction from baseline in MADRS total score. The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS total score was calculated as the sum of the 10 individual item scores. Each item yields a score of 0 (no symptoms) to 6 (symptoms of maximum severity). The total MADRS score (sum of all individual items) ranges from 0 (symptoms absent) to 60 (severe depression). Higher MADRS scores indicated more severe depression. Percentages were rounded off to the first decimal point. (NCT04476030)
Timeframe: Day 15

Interventionpercentage of participants (Number)
Placebo + Assigned ADT48.2
SAGE-217 + Assigned ADT51.6

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Percentage of Participants With MADRS Remission at Day 15

MADRS remission was defined as having a MADRS total score of ≤10. The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS total score was calculated as the sum of the 10 individual item scores. Each item yields a score of 0 (no symptoms) to 6 (symptoms of maximum severity). The total MADRS score (sum of all individual items) ranges from 0 (symptoms absent) to 60 (severe depression). Higher MADRS scores indicated more severe depression. Percentages were rounded off to the first decimal point. (NCT04476030)
Timeframe: Day 15

Interventionpercentage of participants (Number)
Placebo + Assigned ADT28.4
SAGE-217 + Assigned ADT30.9

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Change From Baseline in the HAMD-17 Total Score at Day 3

The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. A negative change from baseline indicated improvement. Least Squares (LS) mean was estimated using mixed effects model for repeated measures (MMRM) analysis. (NCT04476030)
Timeframe: Baseline, Day 3

Interventionscore on a scale (Least Squares Mean)
Placebo + Assigned ADT-7.0
SAGE-217 + Assigned ADT-8.9

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Change From Baseline in the HAMD-17 Total Score Over the Double-Blind Treatment Period

The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. A negative change from baseline indicated improvement. LS mean was estimated using MMRM analysis. The data reported is summary of data collected and analyzed during double-blind treatment period at Baseline, Day 3, Day 8, Day 12, and Day 15 using equal weights for the scheduled visits. (NCT04476030)
Timeframe: Baseline through Day 15

Interventionscore on a scale (Least Squares Mean)
Placebo + Assigned ADT-10.1
SAGE-217 + Assigned ADT-11.7

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Time to First HAMD-17 Response

HAM-D response was defined as having a 50% or greater reduction from baseline in HAM-D total score. The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. Time (in days) from first dose of study drug to time of first HAMD response was reported in this outcome measure. (NCT04476030)
Timeframe: From first dose of study drug up to first HAMD-17 response (up to approximately 65 days)

Interventiondays (Median)
Placebo + Assigned ADT15
SAGE-217 + Assigned ADT13

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Change From Baseline in the HAMD-17 Total Score at Days 15 and 42

The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. A negative change from baseline indicated improvement. LS mean was estimated using MMRM analysis. The missing values were imputed for the analysis. (NCT04476030)
Timeframe: Baseline, Days 15 and 42

,
Interventionscore on a scale (Least Squares Mean)
Day 15Day 42
Placebo + Assigned ADT-12.9-14.9
SAGE-217 + Assigned ADT-13.7-14.9

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Percentage of Participants With CGI-I Response, at Day 3 and Day 15

"CGI-I response was defined as having a CGI-I score of very much improved or much improved. The CGI-I employs a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to IP. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. By definition, all CGI-I assessments are evaluated against baseline conditions. Higher scores indicated worse condition. Percentages were rounded off to the first decimal point." (NCT04476030)
Timeframe: Days 3 and 15

,
Interventionpercentage of participants (Number)
Day 3Day 15
Placebo + Assigned ADT12.954.3
SAGE-217 + Assigned ADT22.956.6

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Change From Baseline in the HAMD-17 Total Score Around End of Blinded Treatment

The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. A negative change from baseline indicated improvement. End of blinded treatment was defined as the average of change from baseline values of Days 12, 15 and 18. LS mean was estimated using MMRM analysis. (NCT04476030)
Timeframe: Baseline, End of blinded treatment assessment (i.e., average of Days 12, 15 , and 18)

Interventionscore on a scale (Least Squares Mean)
Placebo + Assigned ADT-12.7
SAGE-217 + Assigned ADT-13.2

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Percentage of Participants With HAMD-17 Response at Day 15 and Day 42

HAM-D response was defined as having a 50% or greater reduction from baseline in HAM-D total score. The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. Percentages were rounded off to the first decimal point. (NCT04476030)
Timeframe: At Days 15 and 42

,
Interventionpercentage of participants (Number)
Day 15Day 42
Placebo + Assigned ADT49.265.3
SAGE-217 + Assigned ADT53.459.9

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Change From Baseline in MADRS Total Score at Day 15

The MADRS is a 10-item diagnostic questionnaire used to measure the severity of depressive episodes in participants with mood disorders. The MADRS total score was calculated as the sum of the 10 individual item scores. Each item yields a score of 0 (no symptoms) to 6 (symptoms of maximum severity). The total MADRS score (sum of all individual items) ranges from 0 (symptoms absent) to 60 (severe depression). Higher MADRS scores indicated more severe depression. A negative change from baseline indicated improvement. LS mean was estimated using MMRM analysis. (NCT04476030)
Timeframe: Baseline and Day 15

Interventionscore on a scale (Least Squares Mean)
Placebo + Assigned ADT-15.9
SAGE-217 + Assigned ADT-17.2

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Change From Baseline in HAM-A Total Score at Day 15

Each of the 14 items in the HAM-A was defined by a series of symptoms, and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints). The HAM-A total score was calculated as sum of the 14 individual item scores, each rated on a five point scale ranging from 0 (not present) to 4 (very severe). The total score (sum of all individual items) range from 0 to 56, where <17 indicated mild severity, 18 to 24 indicated mild to moderate severity, and 25 to 30 indicated moderate to severe severity. Higher scores indicated more severe disease. Negative change from baseline indicated improvement. LS mean was estimated using MMRM analysis. (NCT04476030)
Timeframe: Baseline, Day 15

Interventionscore on a scale (Least Squares Mean)
Placebo + Assigned ADT-9.0
SAGE-217 + Assigned ADT-9.5

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Change From Baseline in Depressive Symptoms at Day 15, as Assessed by PHQ-9

The PHQ-9 is a participant-rated depressive symptom severity scale. The PHQ-9 total score is calculated as the sum of the 9 individual item scores. For individual items, scoring is based on responses to specific questions, as follows: 0 = not at all; 1 = several days; 2 = more than half the days; and 3 = nearly every day. The PHQ-9 possible total score range is 0 to 27, with higher scores reflecting greater depressive symptoms, and is categorized as follows: 0 to 4 = minimal depression, 5 to 9 = mild depression, 10 to 14 = moderate depression, 15 to 19 = moderately severe depression, and 20 to 27 = severe depression. Negative change from baseline indicated improvement. LS mean was estimated using MMRM analysis. (NCT04476030)
Timeframe: Baseline and Day 15

Interventionscore on a scale (Least Squares Mean)
Placebo + Assigned ADT-8.7
SAGE-217 + Assigned ADT-8.9

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Percentage of Participants With HAMD-17 Remission at Day 15 and Day 42

HAM-D remission was defined as having a HAM-D total score of ≤7. The 17-item HAM-D scale is used to assess the severity of depression. It is comprised of individual ratings related to following symptoms: depressed mood, feelings of guilt, suicide, insomnia, work and activities, retardation, agitation, anxiety, somatic symptoms, genital symptoms, hypochondriasis, loss of weight, and insight. Individual items are scored on either 3-point (0=none to 2=severe) or 5-point scale (0=none/absent to 4=most severe). Total score is the sum of individual items, ranging from 0 (not depressed) to 52 (severely depressed); where a higher score indicates more depression. Percentages were rounded off to the first decimal point. (NCT04476030)
Timeframe: Days 15 and 42

,
Interventionpercentage of participants (Number)
Day 15Day 42
Placebo + Assigned ADT21.839.2
SAGE-217 + Assigned ADT29.137.9

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Change in Hamilton Rating Score for Depression (HRSD) From Baseline to Week 8

Our target is depressive symptomatology as measured by the Hamilton Rating Scale for Depression (HRSD). The HRSD is a 24-item questionnaire used as an indication of depression and a guide to evaluating recovery. Total scores range from 0-74, not including atypical symptoms sub-scale. A score above 16 is typically considered to indicate the presence of depressive symptoms. Higher scores indicate greater severity. The change in Hamilton Rating Score for Depression (HRSD) from baseline to week 8 was calculated as Week 8 HRSD - Baseline HRSD. (NCT04697693)
Timeframe: Baseline and Week 8

Interventionscore on a scale (Mean)
Treatment With Escitalopram or Duloxetine3

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